NCT00964340

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

A Randomized, Placebo-Controlled, Double-Blind, Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a double-blind, randomized, parallel group, placebo-controlled study of healthy 60-80 year old community-dwelling male and female subjects. The study consists of 8 outpatient clinic visits, 2 inpatient clinic visits and 8 telephone contacts (including the pre-screening call to determine a subject's interest in participation). Subjects will undergo a preliminary telephone pre-screening assessment to determine their interest in participating in the study. Once interest has been confirmed, subjects will sign an informed consent and undergo screening procedures. Subjects meeting the inclusion and exclusion criteria will be enrolled in the study and randomized to receive either 0.5 g/day of SRT2104, 2.0 g/day of SRT2104 or placebo once daily for up to 28 consecutive days. After the completion of the screening assessments and confirmation of eligibility, subjects will return to the site on Day -9 and will undergo a practice endurance testing session. In addition, on Day -9 subjects will be given a pedometer which they will be asked to wear while awake for 7 consecutive days from Day -8 and 7 consecutive days from Day 20 to estimate daily physical mobility levels in the home environment. Subjects will return to the site on Days -1 and 27 for safety assessments, MRI/MRS assessments and exercise endurance tests. On Days 1 and 28 subjects will be admitted overnight as inpatients. PK samples will be collected through 24 hours post-dose on Days 2 and 29. During the dosing period safety visits will be performed on approximately Days 7, 14, and 21. Additional telephone safety assessments will be made approximately on Days 3, 5, 10, 17, 20 and 24. The End of Dosing Follow-up visit will be performed approximately 35 days following the first dose of SRT2104 or placebo. An additional follow up safety telephone call will be made to each subject 30 days following their final dose of SRT2104 and/or placebo. The end of the study is defined as the last subject's last assessment (i.e. Day 58, the date of the last subject communication). Subjects will be instructed to self administer test material at home on study days 3-27. All study visits are outpatient visits except for Day 1 and Day 28. Subjects will stay overnight at the site the evening of Day 1 and Day 28. On Day 2 and Day 29 subjects will be discharged home following the completion of study assessments and when considered clinically appropriate by the study physician.

Conditions

• Atrophy, Muscular

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-27
• Completion: 2010-04-27
• First posted: 2009-08-24
• Last updated: 2017-06-16

Locations

1 site across 1 country: United Kingdom