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NCT01756495 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin
A Phase 1 study of Acute Coronary Syndrome, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT01756495: Completed Phase 1 study of Acute Coronary Syndrome, sponsored by GlaxoSmithKline.
NCT01756495 is a Phase 1 study of Acute Coronary Syndrome that has completed, run by GlaxoSmithKline. The registered enrollment target is 56 participants, below the 2,720-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756495, a Phase 1 study of Acute Coronary Syndrome, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc interval prolongation; therefore, it will serve as a positive control to validate the ability of this study to detect a change in the QTc interval. All subjects will participate in 4 study periods separated by a minimum washout period of 5 days. Each subject will receive one of 4 regimens (A = Losmapimod 7.5 milligram \[mg\] Twice daily \[BID\] x 5 days, B = Losmapimod 20 mg Once daily \[QD\] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14 days after end of Period 4
Primary Outcome
Triplicate ECGs will be collected at three baseline pre-dose time points (at -45 min, -30 min and -15 min) on Day 1 of the corresponding study period. Period baseline will be the average of triplicate pre-dose assessments. Triplicate Holter ECGs measurements will be evaluated at 14 post-dose time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and 24 hours) on Day 5 of the corresponding study period and will be averaged prior to calculation of changes from period baseline and statistical an
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Moxifloxacin Placebo
- DRUG Losmapimod
- DRUG Losmapimod matched Placebo
Study Locations (1)
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-01-10 |
| Est. Completion | 2013-04-23 |
| Phase | Phase 1 |
What the finished NCT01756495 record still lists
NCT01756495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 2,720-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT01756495 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01756495 about?
NCT01756495 is a clinical study titled "A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin". This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corre...
What is the current status of trial NCT01756495?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2013-01-10. Estimated completion is 2013-04-23.
What conditions does trial NCT01756495 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome.
What interventions are being tested in trial NCT01756495?
The interventions under investigation include: Moxifloxacin (DRUG), Moxifloxacin Placebo (DRUG), Losmapimod (DRUG), Losmapimod matched Placebo (DRUG).
Who is sponsoring clinical trial NCT01756495?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01756495 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01756495's enrollment target sits among peer trials
56 37th of 40 higher than 4 of 40 other Acute Coronary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Coronary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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