A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
NCT05818852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2024-03-20
Summary
The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.
Conditions
Interventions
- DRUG
-
VX-548
Tablets for oral administration.
- DRUG
-
Moxifloxacin
Capsules for oral administration.
- DRUG
-
Moxifloxacin Placebo
Capsules for oral administration.
- DRUG
-
VX-548 Placebo
Tablets for oral administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-12
- Primary Completion
- 2023-06-12
- Completion
- 2023-06-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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