An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: 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), both inclusive

• Male and female participants of age 18 to 45 years, both inclusive

• Serum potassium, calcium, and magnesium values within normal ranges

Key Exclusion Criteria:

• Median QTcF>450 msec on triplicate 12-lead ECGs

• History of conduction abnormalities

Other protocol defined Inclusion/Exclusion criteria may apply.