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A Clinical Study to Assess the Effect of Food and Gender on the Pharmacokinetics of SRT2104 Administered as an Oral Suspension or Capsule Formulation to Normal Healthy Volunteers

NCT00938275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-21

No results posted yet for this study

Summary

The primary objective of this study is to assess the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal healthy male and female volunteers in both the fed and fasted state.

The secondary objective is to assess the safety and tolerance of SRT2104 administered as an oral suspension and as a capsule formulation to healthy male and female volunteers in both the fed and fasted state.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

0.5g SRT2104

SRT2104 will be supplied in two forms: as 0.5g powder which will be prepared by the pharmacist/designee into a liquid suspension and as two hard gelatin capsules, each containing 0.25g SRT2104. The dosing vehicle for the liquid suspension is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104. Each formulation of test material will be administered orally, in a single dose to the subjects in the fasted state and following consumption of a standard meal. Neither the investigator nor the subjects enrolled will be blinded to treatment assignment.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sirtris, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-20
Primary Completion
2009-03-27
Completion
2009-03-27

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 NCT00938275 on ClinicalTrials.gov