Overview
A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-07-01
2023-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Vertex Pharmaceuticals IncorporatedTreatments:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Criteria
Key Inclusion Criteria:- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2)
- A total body weight greater than (>) 50 kilogram (kg)
Key Exclusion Criteria:
- History of febrile illness within 5 days before the first dose of study drug
- Any condition possibly affecting drug absorption
- Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones
Other protocol defined Inclusion/Exclusion criteria may apply.