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Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers

NCT00933062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-07-07

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetic profile, safety, and tolerability of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

SRT2104

2.0 g of SRT2104 will be supplied in hard gelatin capsules each containing 250 mg SRT2104. SRT2104 will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of SRT2104 will be orally-administered with approximately 200 mL water.

DRUG

Placebo

Placebo will be supplied in hard gelatine capsules containing an appropriate amount of placebo. Placebo will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of placebo will be orally-administered with approximately 200 mL water.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-23
Primary Completion
2009-05-12
Completion
2009-05-12

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933062 on ClinicalTrials.gov