NCT01340911

A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases

A Randomized, Placebo-Controlled, Single-Blind, Dose-Escalation, First-Time-in-Human Study to Assess the Safety and Pharmacokinetics of Single and Repeat Doses of SRT3025 in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Sirtris, a GSK Company · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of the study is to see how safe SRT3025 (study drug) is when given at different doses. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how taking the study drug after eating might change this process.

Detailed description

SRT3025 is being developed for the treatment of metabolic diseases. This study is the first administration of SRT3025 in humans and seeks to establish the initial safety, tolerability, and pharmacokinetic (PK) profile of SRT3025 (and any metabolites, if analyzed) before proceeding to future Phase 1 studies or Phase 2 patient studies. This protocol details a Phase 1, randomized, placebo-controlled, single-blind, dose escalation study to determine the safety, tolerability, and PK profile of SRT3025 in healthy male subjects. The study will be conducted in two parts. In Part 1A, 6 Cohorts of subjects will receive single escalating doses of SRT3025. In Part 1B, an additional one to two cohorts may be enrolled to investigate the effect of a moderate fat/calorie meal on single dose PK endpoints. In Part 2A, up to three cohorts may be enrolled to receive 14-day repeat doses of SRT3025 chosen from the Part 1A safety, tolerability, and PK data. In Part 2B, one to two additional cohorts may receive 14-day repeat doses of SRT3025 in combination with a moderate fat/calorie meal.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	SRT3025	SRT3025 will be supplied as hard gelatin capsules containing either 27.4 mg (25 mg SRT3025 free base equivalent) or 274 mg (250 mg SRT3025 free base equivalent) of SRT3025 HCl monohydrate drug substance.
DRUG	Placebo	For placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product.

Timeline

• Start date: 2011-06-03
• Primary completion: 2011-11-24
• Completion: 2011-11-24
• First posted: 2011-04-25
• Last updated: 2017-10-30

Locations

1 site across 1 country: United Kingdom