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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04865393




Registration number
NCT04865393
Ethics application status
Date submitted
26/04/2021
Date registered
29/04/2021

Titles & IDs
Public title
Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function
Scientific title
A Phase 1, Open-label Study to Assess the Safety and Pharmacokinetics of SPR206 Following a Single IV Dose of SPR206 in Subjects With Varying Degrees of Renal Function
Secondary ID [1] 0 0
CDMRP-JW180095-B
Secondary ID [2] 0 0
SPR206-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Impairment 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPR206

Experimental: SPR206 - SPR206 100mg single-dose IV infused over 1 hour


Treatment: Drugs: SPR206
SPR206 100 mg single-dose IV infused over 1 hour
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to the maximum plasma concentration (Tmax)
Timepoint [1] 0 0
36 hours after start of study drug IV infusion
Primary outcome [2] 0 0
Maximum plasma concentration (Cmax)
Timepoint [2] 0 0
36 hours after start of study drug IV infusion
Primary outcome [3] 0 0
Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t)
Timepoint [3] 0 0
36 hours after start of study drug IV infusion
Primary outcome [4] 0 0
Area under the concentration-time curve from time 0 to infinity (AUC0-8)
Timepoint [4] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [1] 0 0
Area under the concentration-time curve from time 0 to 8 hours (AUC0-8)
Timepoint [1] 0 0
8 hours after start of study drug IV infusion
Secondary outcome [2] 0 0
Terminal Elimination Rate Constant (kel)
Timepoint [2] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [3] 0 0
Terminal half-life (t1/2)
Timepoint [3] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [4] 0 0
Total body clearance (CL)
Timepoint [4] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [5] 0 0
Renal clearance (CLR)
Timepoint [5] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [6] 0 0
Steady-state volume of distribution (Vss)
Timepoint [6] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [7] 0 0
Amount of drug excreted in urine by interval (Aet) for Cohorts 1-4
Timepoint [7] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [8] 0 0
Cumulative amount of drug excreted in urine at the end of each interval (Aeu) for Cohorts 1-4
Timepoint [8] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [9] 0 0
Fraction of drug excreted in the urine expressed as a percentage (Ae%) for Cohorts 1-4
Timepoint [9] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [10] 0 0
Fraction of dose excreted in the urine over a collection interval (Fe) for Cohorts 1-4
Timepoint [10] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [11] 0 0
Cumulative fraction of dose excreted in the urine over (Feu) for Cohorts 1-4
Timepoint [11] 0 0
36 hours after start of study drug IV infusion
Secondary outcome [12] 0 0
Extraction ratio (ER) for subjects on dialysis (Cohort 5)
Timepoint [12] 0 0
Up to 1 day post dose - between start and end of hemodialysis
Secondary outcome [13] 0 0
Estimated hemodialysis clearance (CLHD) for subjects on dialysis (Cohort 5)
Timepoint [13] 0 0
Up to 1 day post dose - between start and end of hemodialysis
Secondary outcome [14] 0 0
Amount of the dose removed by hemodialysis (XHD) for subjects on dialysis (Cohort 5)
Timepoint [14] 0 0
Up to 1 day post dose - between start and end of hemodialysis
Secondary outcome [15] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [15] 0 0
14 days post start of last study drug IV infusion
Secondary outcome [16] 0 0
Incidence of abnormal vital sign assessments - blood pressure
Timepoint [16] 0 0
14 days post study drug IV infusion
Secondary outcome [17] 0 0
Incidence of abnormal vital sign assessments - body temperature
Timepoint [17] 0 0
14 days post study drug IV infusion
Secondary outcome [18] 0 0
Incidence of abnormal physical exam assessments
Timepoint [18] 0 0
14 days post study drug IV infusion
Secondary outcome [19] 0 0
Incidence of abnormal ECG assessments - heart rate
Timepoint [19] 0 0
14 days post study drug IV infusion
Secondary outcome [20] 0 0
Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval
Timepoint [20] 0 0
14 days post study drug IV infusion
Secondary outcome [21] 0 0
Incidence of abnormal safety laboratory assessments
Timepoint [21] 0 0
14 days post study drug IV infusion

Eligibility
Key inclusion criteria
Key

* BMI = 18.5 and = 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive)
* Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees of Renal Disease)
* Normal renal function with eGFR =90 mL/min/1.73m2 (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m2 (Cohort 2), 30 to <60 mL/min/1.73m2 (Cohort 3), or <30 mL/min/1.73m2 (Cohort 4), calculated using Modification of Diet in Renal Disease (MDRD). Subjects with ESRD must be receiving hemodialysis at least 3 times per week for at least 3 months at Screening (Cohort 5 only)
* Non-smoker for at least 1 month prior to screening for the study
* Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food
* Other inclusion criteria per protocol

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
* Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
* Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB <8.5 gm/dL, WBC =3,000 cells/µL or platelet count =100,000 cells/µL (Cohorts 2-5)
* Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory
* Recent history (within 6 months) of known or suspected Clostridium difficile infection
* History of chronic liver disease, cirrhosis, or biliary disease
* History of seizure disorder except childhood history of febrile seizures
* Positive urine drug/alcohol testing
* Positive testing for human immunodeficiency virus1/2 (HIV 1/2), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies
* History of substance abuse or alcohol abuse
* Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
* Other exclusion criteria per protocol

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2021
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spero Therapeutics
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
United States Department of Defense
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Melnick, MD
Address 0 0
Spero Therapeutics Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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 not provided in https://clinicaltrials.gov/study/NCT04865393