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NCT02231190 · ClinicalTrials.gov registry record · Phase 1
GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT02231190 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 26 participants.
The verdict
NCT02231190, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study 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).
Interventions
- DRUG Placebo
- DRUG GSK1278863
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-01-15 |
| Est. Completion | 2015-06-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02231190
The ClinicalTrials.gov registry entry for NCT02231190 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02231190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02231190 about?
NCT02231190 is a clinical study titled "GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage". 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 ec...
What is the current status of trial NCT02231190?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2015-01-15. Estimated completion is 2015-06-12.
What interventions are being tested in trial NCT02231190?
The interventions under investigation include: Placebo (DRUG), GSK1278863 (DRUG).
Who is sponsoring clinical trial NCT02231190?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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