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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02533427
Registration number
NCT02533427
Ethics application status
Date submitted
24/08/2015
Date registered
26/08/2015
Titles & IDs
Public title
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
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Scientific title
A Phase 1, Open-Label, Drug Interaction Study Evaluating the Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
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Secondary ID [1]
0
0
GS-US-367-1909
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HCV Infection
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Other infectious diseases
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SOF/VEL/VOX
Treatment: Drugs - VOX
Treatment: Drugs - Norgestimate/ethinyl estradiol
Experimental: SOF/VEL/VOX + VOX - Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol for at least one menstrual cycle will receive norgestimate/ethinyl estradiol. Participants with a documented history of taking norgestimate/ethinyl estradiol may enroll directly into Part B of the study.
Part B: Participants will continue taking norgestimate/ethinyl estradiol for the remainder of the study and will receive SOF/VEL/VOX FDC plus VOX.
Treatment: Drugs: SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily
Treatment: Drugs: VOX
100 mg tablet administered orally once daily
Treatment: Drugs: Norgestimate/ethinyl estradiol
Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin
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Assessment method [1]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [1]
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0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [2]
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PK Parameter: AUCtau of Norgestrel
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Assessment method [2]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [2]
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0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [3]
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PK Parameter: AUCtau of Ethinyl Estradiol
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Assessment method [3]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [3]
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0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [4]
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0
Pharmacokinetic (PK) Parameter: AUCtau of Norgestimate
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Assessment method [4]
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0
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [4]
0
0
Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [5]
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0
PK Parameter: Cmax of Norelgestromin
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Assessment method [5]
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0
Cmax is defined as the maximum concentration of drug.
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Timepoint [5]
0
0
Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [6]
0
0
PK Parameter: Cmax of Norgestrel
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Assessment method [6]
0
0
Cmax is defined as the maximum concentration of drug.
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Timepoint [6]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [7]
0
0
PK Parameter: Cmax of Ethinyl Estradiol
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Assessment method [7]
0
0
Cmax is defined as the maximum concentration of drug.
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Timepoint [7]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [8]
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0
PK Parameter: Cmax of Norgestimate
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Assessment method [8]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [8]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [9]
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0
PK Parameter: Ctau of Norelgestromin
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Assessment method [9]
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0
Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [9]
0
0
Part A:Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Part B:Cycle 2,Study Day 42:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [10]
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0
PK Parameter: Ctau of Norgestrel
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Assessment method [10]
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0
Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [10]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [11]
0
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PK Parameter: Ctau of Ethinyl Estradiol
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Assessment method [11]
0
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [11]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Primary outcome [12]
0
0
PK Parameter: Ctau of Norgestimate
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Assessment method [12]
0
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [12]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose;Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [1]
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Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
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Assessment method [1]
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0
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Timepoint [1]
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First dose date up to the last dose date (maximum: 84 days) plus 10 days
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Secondary outcome [2]
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Percentage of Participants Who Experienced Laboratory Abnormalities
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Assessment method [2]
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0
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Grade 1: mild; Grade 2: moderate;Grade 3: severe or medically significant but not immediately life-threatening; Grade 4: life-threatening consequences.
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Timepoint [2]
0
0
First dose date up to the last dose date (maximum: 84 days) plus 10 days
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Secondary outcome [3]
0
0
PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate
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Assessment method [3]
0
0
Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [3]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [4]
0
0
PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate
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Assessment method [4]
0
0
Tlast is defined as the time (observed time point) of Clast.
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Timepoint [4]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [5]
0
0
PK Parameter: ?z of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate
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Assessment method [5]
0
0
?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [5]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [6]
0
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PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate
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Assessment method [6]
0
0
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [6]
0
0
Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [7]
0
0
PK Parameter: CLss/F Ethinyl Estradiol, and Norgestimate
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Assessment method [7]
0
0
CLss/F is defined as the apparent steady state oral clearance following administration of the drug.
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Timepoint [7]
0
0
\Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [8]
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PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX)
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Assessment method [8]
0
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Cmax is defined as the maximum concentration of drug.
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Timepoint [8]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [9]
0
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PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX
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Assessment method [9]
0
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [9]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [10]
0
0
PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX
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Assessment method [10]
0
0
Tlast is defined as the time (observed time point) of Clast.
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Timepoint [10]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [11]
0
0
PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX
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Assessment method [11]
0
0
Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [11]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [12]
0
0
PK Parameter: ?z of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX
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Assessment method [12]
0
0
?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [12]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [13]
0
0
PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX
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Assessment method [13]
0
0
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [13]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [14]
0
0
PK Parameter: CLss/F of SOF, VEL, and VOX
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Assessment method [14]
0
0
CLss/F is defined as the apparent steady state oral clearance following administration of the drug.
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Timepoint [14]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Secondary outcome [15]
0
0
PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX
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Assessment method [15]
0
0
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [15]
0
0
Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
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Eligibility
Key inclusion criteria
* Premenopausal female
* Must have a calculated body mass index (BMI) = 19.0 and = 30.0 kg/m^2 at screening
* Must have a negative serum pregnancy test at screening and urine pregnancy test at Day -1
* Be willing and able to comply with all study requirements.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Lactating female
* Have a history of any of the following:
* Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
* Known hypersensitivity to the study drugs, the metabolites or formulation excipients
* Believed, by the study investigator, to be inappropriate for study participation for any reason
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/03/2016
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
New Zealand
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State/province [1]
0
0
Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.
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Trial website
https://clinicaltrials.gov/study/NCT02533427
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Gilead Study Director
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Address
0
0
Gilead Sciences
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02533427