Overview

A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor

Status:
Not yet recruiting
Trial end date:
2022-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Criteria
Key Inclusion Criteria:

- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both
inclusive

- A total body weight greater than (>)50 kg

Key Exclusion Criteria:

- History of febrile illness or other acute illness that has not fully resolved within
14 days before the first dose of study drug

- Any condition possibly affecting drug absorption

- Female participants who are pregnant, nursing, or planning to become pregnant during
the study or 90 days after the last dose of the study drug

- Male participants with a female partner who is pregnant, nursing, or planning to
become pregnant during the study

- History of cardiovascular disease or central nervous system disease

Other protocol defined Inclusion/Exclusion criteria may apply.