Trials / Completed
CompletedNCT01910415
Phase 1, QT/QTC Interval Study in Healthy Subjects
A Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to evaluate the effect of multiple doses of lumacaftor in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lumacaftor | |
| DRUG | Lumacaftor Placebo | |
| DRUG | Ivacaftor | |
| DRUG | Ivacaftor Placebo | |
| DRUG | moxifloxacin hydrochloride |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2013-07-29
- Last updated
- 2014-08-11
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01910415. Inclusion in this directory is not an endorsement.