Phase 1, QT/QTC Interval Study in Healthy Subjects
NCT01910415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2014-08-11
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
- DRUG
-
Lumacaftor
- DRUG
-
Lumacaftor Placebo
- DRUG
-
Ivacaftor
- DRUG
-
Ivacaftor Placebo
- DRUG
-
moxifloxacin hydrochloride
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2014-03-31
- Completion
- 2014-03-31
Countries
- Netherlands
Study Locations
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