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A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days

NCT00964340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-16

No results posted yet for this study

Summary

The primary objective is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing.

The secondary objectives of the study are:

1. To contrast changes in leg muscle function following repeat doses of SRT2104 or placebo:

Endurance exercise tolerance 31P MRS measures of mitochondrial oxidative capacity in the gastrocnemius muscle
2. To test for a change in the ratio of visceral to subcutaneous body fat following repeat doses of SRT2104 relative to placebo using MRI
3. To estimate any changes in insulin sensitivity (using mOGTT) following repeat doses of SRT2104 or placebo
4. To test for dose-related effects on the exploratory pharmacodynamic measures above

Conditions

  • Atrophy, Muscular

Interventions

DRUG

Placebo

For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product. The ratio of active to placebo capsules will vary according to the subject's dosing level.

DRUG

SRT2104

SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of the SRT2104 powder into a size 00 opaque capsule, which is then stored in dosing bottles.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2010-04-27
Completion
2010-04-27

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT00964340 on ClinicalTrials.gov