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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02616445




Registration number
NCT02616445
Ethics application status
Date submitted
5/11/2015
Date registered
30/11/2015

Titles & IDs
Public title
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects
Scientific title
A Phase I Double-Blind, Randomised, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UE2343 in Healthy Subjects
Secondary ID [1] 0 0
ACW0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UE2343
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - UE2343
Treatment: Drugs - UE2343

Placebo comparator: MAD Study -

Placebo comparator: Fed-Fasted -

Experimental: CSF -


Treatment: Drugs: UE2343
* UE2343
* 10mg, 20, 35mg
* twice daily for 9 days

Treatment: Drugs: Placebo
* 10mg, 20, 35mg
* twice daily for 9 days

Treatment: Drugs: Placebo
* Cross-over study
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

Treatment: Drugs: UE2343
* Cross-over study
* UE2343
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

Treatment: Drugs: UE2343
* UE2343
* twice daily for 3 days
* single dose on day 4
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess Safety and Tolerability of UE2343 over 17 days including AEs, 12-lead ECGs, vital signs, Nerve conduction velocity, Labs.
Timepoint [1] 0 0
Up to Day 17
Primary outcome [2] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Maximum Plasma Concentration (Cmax) of UE2343 after a single dose
Timepoint [2] 0 0
Day 1 and Day 8
Primary outcome [3] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Time to Cmax (Tmax) of UE2343 after a single dose
Timepoint [3] 0 0
Day 1 and Day 8
Primary outcome [4] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Area Under the Curve (AUC) of UE2343 after a single dose
Timepoint [4] 0 0
Day 1 and Day 8
Primary outcome [5] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Terminal Elimination Half Life (t½) of UE2343 after a single dose
Timepoint [5] 0 0
Day 1 and Day 8
Primary outcome [6] 0 0
Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF
Timepoint [6] 0 0
Day 4
Secondary outcome [1] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Maximum Plasma Concentration (Cmax) from time of dosing to 12 hours
Timepoint [1] 0 0
Day 1 and Day 10
Secondary outcome [2] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Time to Cmax (Tmax) from time of dosing to 12 hours
Timepoint [2] 0 0
Day 1 and Day 10
Secondary outcome [3] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Area Under the Curve (AUC) from time of dosing to 12 hours
Timepoint [3] 0 0
Day 1 and Day 10
Secondary outcome [4] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Terminal Elimination Half Life (t½) from time of dosing to 12 hours
Timepoint [4] 0 0
Day 1 and Day 10
Secondary outcome [5] 0 0
Assess Pharmacokinetics (PK) Urine parameters (Amount of drug excreted in urine (Ae) and Ae as a % of dose) from time of dosing to 24 hours
Timepoint [5] 0 0
Day 1 and Day 10
Secondary outcome [6] 0 0
Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF compared to the Cmax value obtained in plasma
Timepoint [6] 0 0
Day 4
Secondary outcome [7] 0 0
Assess Pharmacodynamics (PD) Blood parameter Adrenocorticotropic hormone (ACTH) from baseline to end of study
Timepoint [7] 0 0
Days 1, 10, 11, 12, 13 and 17.
Secondary outcome [8] 0 0
Assess Pharmacodynamics (PD) Blood parameter Serum Cortisol from baseline to end of study
Timepoint [8] 0 0
Days 1, 10, 11, 12, 13 and 17.
Secondary outcome [9] 0 0
Assess Pharmacodynamics (PD) Blood parameter for Adrenal Androgens from baseline to end of study
Timepoint [9] 0 0
Days 1, 10, 11, 12, 13 and 17.
Secondary outcome [10] 0 0
Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisol (UFF) from baseline to end of study
Timepoint [10] 0 0
Days 1, 10, 11 and 12
Secondary outcome [11] 0 0
Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisone (UFE) from baseline to end of study
Timepoint [11] 0 0
Days 1, 10, 11 and 12
Secondary outcome [12] 0 0
Assess Pharmacodynamics (PD) Urine parameter 5a-tetrahydrocortisol (5aTHF) from baseline to end of study
Timepoint [12] 0 0
Days 1, 10, 11 and 12
Secondary outcome [13] 0 0
Assess Pharmacodynamics (PD) Urine parameter 5ß-tetrahydrocortisol (5ßTHF) from baseline to end of study
Timepoint [13] 0 0
Days 1, 10, 11 and 12
Secondary outcome [14] 0 0
Assess Pharmacodynamics (PD) Urine parameter tetrahydrocortisone (THE) from baseline to end of study
Timepoint [14] 0 0
Days 1, 10, 11 and 12

Eligibility
Key inclusion criteria
* Willing to use specified contraception
* BMI within specified range
* No clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Abnormal medical history, including history of dementia
* No significant allergic reactions
* No prior drug or alcohol abuse
* Use of regular prescribed medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
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
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actinogen Medical
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Linear Clinical Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Vincent Ruffles
Address 0 0
Actinogen Medical
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

TypeCitations or Other Details
Journal Webster SP, McBride A, Binnie M, Sooy K, Seckl JR,... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02616445