GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage
Status:
Completed
Trial end date:
2015-06-12
Target enrollment:
Participant gender:
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).