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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04887038




Registration number
NCT04887038
Ethics application status
Date submitted
5/05/2021
Date registered
14/05/2021
Date last updated
20/04/2022

Titles & IDs
Public title
First-in-Human Study of SRT-015 in Healthy Subjects.
Scientific title
A Single and Multiple Dose-escalation First-in-human With Food-effect Study Evaluating the Safety, Tolerability and Pharmacokinetics of SRT-015 Administered Orally.
Secondary ID [1] 0 0
SRT015-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SRT-015
Other interventions - Matching Placebo for SRT-015

Active comparator: Drug :SRT-015 - Experimental, Single and Multiple Oral escalating dose and Food Effect Cohort

Placebo comparator: Matching Placebo for SRT-015 -


Treatment: Drugs: SRT-015
Each study part (A,B and C) will be completed sequentially, but with partial overlapping. The first cohort of Part B (Cohort B1) may be initiated after safety, tolerability and available PK data are assessed and deemed suitable to continue for a single dose on Part A that is equal to or greater than the total exposure of cohort B1. Part C (Cohort C1 \& C2) may be initiated after safety, tolerability and PK data are assessed and deemed suitable to continue for a single dose in part A that is at least double the specified dose from part C.

Other interventions: Matching Placebo for SRT-015
Matching Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability following of single and multiple oral doses of SRT-015 in healthy subjects
Timepoint [1] 0 0
Up to two weeks
Primary outcome [2] 0 0
To evaluate the exposure to SRT-015 following single and multiple oral dose administration in healthy subjects (AUC last)
Timepoint [2] 0 0
Up to two weeks
Primary outcome [3] 0 0
3. To evaluate maximum serum concentration of SRT-015 following single and multiple oral dose administration in healthy subjects (Cmax)
Timepoint [3] 0 0
Up to two weeks
Secondary outcome [1] 0 0
To compare the exposure to SRT-015 (AUClast) in capsule formulation vs suspension formulation and fed vs fasted state
Timepoint [1] 0 0
Up to two weeks
Secondary outcome [2] 0 0
To compare maximum serum concentration of SRT-015 (Cmax) in capsule formulation vs suspension formulation and fed v fasted state
Timepoint [2] 0 0
Up to two weeks

Eligibility
Key inclusion criteria
Key

1. Males or females aged 18 to 45 years of age with a BMI >18.0 and <32.0 kg/m2 and body weight greater than or equal to 50kg for males and greater than or equal to 45 kg for females.
2. Casual smoker (defined by the consumption of no more than 5 cigarettes per week, and willing to abstain from the consumption of cigarettes and related products for the study duration) or non smoker.
3. Agree to use appropriate contraception.

Key
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results (liver function tests must be strictly within normal ranges) or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
2. Positive urine drug screen or alcohol breath test at screening and check-in (Day -1).
3. Positive pregnancy test, or breast feeding.
4. Clinically significant 12-lead ECG abnormalities.
5. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
3/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2022
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
Melbourn
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Victor Harbor
Recruitment postcode(s) [1] 0 0
3004 - Victor Harbor

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers.

This will be a single center, Phase 1, randomized, double-blind, placebo controlled, SAD and MAD study of dose escalation cohorts evaluating administration of SRT-015 or placebo. Additionally, PK will be assessed in fed and fasting states.
Trial website
https://clinicaltrials.gov/study/NCT04887038
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04887038