First-in-Human Study of SRT-015 in Healthy Subjects.

NCT04887038 | Completed Phase 1

• 1 other identifier: SRT015-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (3)

• To evaluate the safety and tolerability following of single and multiple oral doses of SRT-015 in healthy subjects

  Number of participants with serious and other non-serious adverse events

  Up to two weeks

• To evaluate the exposure to SRT-015 following single and multiple oral dose administration in healthy subjects (AUC last)

  Area under the serum concentration-time curve from time zero to last measurable concentration (mg\*h/L)

  Up to two weeks

• 3. To evaluate maximum serum concentration of SRT-015 following single and multiple oral dose administration in healthy subjects (Cmax)

  Maximum serum concentration (mg/L)

  Up to two weeks

Secondary Outcomes (2)

• To compare the exposure to SRT-015 (AUClast) in capsule formulation vs suspension formulation and fed vs fasted state

  Up to two weeks

• To compare maximum serum concentration of SRT-015 (Cmax) in capsule formulation vs suspension formulation and fed v fasted state

  Up to two weeks

Study Arms (2)

Drug :SRT-015

ACTIVE COMPARATOR

Experimental, Single and Multiple Oral escalating dose and Food Effect Cohort

Drug: SRT-015

Matching Placebo for SRT-015

PLACEBO COMPARATOR

Other: Matching Placebo for SRT-015

Interventions

SRT-015 DRUG

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.

Drug :SRT-015

Matching Placebo for SRT-015 OTHER

Matching Placebo

Matching Placebo for SRT-015

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Agree to use appropriate contraception.

You may not qualify if:

• 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.
• Positive urine drug screen or alcohol breath test at screening and check-in (Day -1).
• Positive pregnancy test, or breast feeding.
• Clinically significant 12-lead ECG abnormalities.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• Syneos Health: lead

Study Sites (1)

Nucleus Network Pty Ltd

Victor Harbor, Melbourne, 3004, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: May 3, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)