NCT02231190

GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage

A Randomized, Placebo-Controlled, Double-Blind (Sponsor Unblinded) Study to Investigate Protective Effects of GSK1278863 on Eccentric Exercise Induced Muscle Damage in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863 on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1 subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral doses of GSK1278863/placebo in total. The first dose will be administered immediately after completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge. After enrolment of approximately 30 subjects, enrolment will be paused and planned interim analysis will be performed to decide whether to terminate enrolment/study, continue dosing or to reduce the dose to 5 milligrams (mg).

Conditions

• Tendon Injuries

Interventions

Type	Name	Description
DRUG	GSK1278863	GSK1278863 will be supplied as oral tablet of strength 100mg, 5mg(5mg if a low dose is elected for subjects enrolled after interim analysis) to be administered with 240 mL of water after end of eccentric exercise
DRUG	Placebo	GSK1278863 matching placebo will be supplied as oral tablets for administration with 240 mL of water after end of eccentric exercise

Timeline

• Start date: 2015-01-15
• Primary completion: 2015-06-12
• Completion: 2015-06-12
• First posted: 2014-09-04
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States