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A Clinical Study to Assess the Effects of SRT2104 Upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers

2014-08-27 03:17:00 | BioPortfolio

Summary

The main purpose of this study is to investigate the effect of SRT2104 upon energy production in muscle (specifically the maximum amount of energy produced with muscle contraction), how much sugar and fat are stored in the muscle, and the size of the muscle after receiving 2.0 g of SRT2104 or placebo given in capsule form once a day for 28 days including a 14 day knee and lower leg immobilisation period during the final 14 days of dosing.

Imaging methods, muscle biopsies and exercise tests will be used in the study to see whether the following measurements change after taking SRT2104 for 28 days, including an immobilised knee and lower leg for the final 14 days of dosing.

i) energy reaching the muscles ii) muscle strength iii) changes in the structure of the muscle

This study will also investigate the pharmacokinetics, safety and tolerability of 2.0 g of SRT2104 administered orally once daily for 28 consecutive days. The investigation of pharmacokinetics of SRT2104 allows us to gather information regarding:

i) how long it takes for the drug to be absorbed and detected in the blood ii) how much we can detect iii) how long we can detect it for iv) how often we need to give the drug to maintain a steady amount in the blood.

SRT2104 will be given to healthy subjects aged between 18 and 40 years old. Subjects will participate in this single centre study for approximately 79 days. The study consists of 11 outpatient clinic visits and 4 telephone calls (including a prescreen call to determine whether subjects are interested in participating).

Description

Participants will take part in a prospective, single center, randomized, double-blind, clinical study of 2.0 g/day of SRT2104 or placebo (test material) administered orally as 0.25 g capsules. The study will evaluate the effect of 28 days of consecutive SRT2104 dosing upon muscle strength, metabolism and structure of the ankle muscle group following a 14 day leg immobilization period. The study will also evaluate pharmacokinetic parameters as well as the safety and tolerability of 2.0 g/day of SRT2104. Thirty-four (34) healthy male and female subjects aged 18-40, who fulfill the inclusion/exclusion criteria, will be enrolled in this study. Subjects will be randomized 1:1 to receive either 2.0 g/day of SRT2104 or placebo in a fed state for 28 consecutive days. Subjects will remain on a fixed dose of test material for all dosing days in the study.

Subjects will provide written informed consent and undergo screening assessments. If eligible and willing to participate, subjects will undergo baseline strength testing, muscle biopsy, MRI, and MRS evaluations on Day -1 to assess muscle strength, and metabolism. Participants will then commence a 28 day dosing period with test material. On the first day of dosing (Day 1), pharmacokinetic and safety assessments will be performed. On Day 15, after subjects have completed 14 days of dosing with test material, participants will repeat the muscle biopsy, strength testing, MRI evaluations, pharmacokinetic and safety assessments. Following the study assessments on Day 15, subjects will commence a 14 day immobilization period. The leg of the dominant leg will be immobilized with a temporary removable brace, and subjects will be instructed to ambulate using crutches for the duration of the immobilization period. Designated site staff will contact subjects via telephone on Day 18 and Day 24 to check on the subjects' wellbeing and ability to function while immobilized. Subjects will report to the study site on Day 21 during the 14 day immobilization period for assessment of the immobilized leg, including safety evaluations. On Day 28, following completion of the 14 day immobilization period, a muscle biopsy, skeletal muscle evaluations, pharmacokinetic and safety assessments will be performed. Subjects will return to the clinic for an End of Study visit 7 days (+/- 2 days) after the last dose of test material for follow up safety assessments. A follow-up safety call will be made to each subject approximately 30 days following their final dose of SRT2104 or placebo.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Conditions

Healthy Volunteer

Intervention

SRT2104, Placebo

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:00-0400

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