Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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
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.
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.
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