A Phase 1, Randomized, Open-label, Crossover Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121, Tezacaftor, and Deutivacaftor in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA
Study Overview
Brief 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).
Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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.
Arms & Interventions
Sequence 1
Participants will receive a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods.
Intervention: VX-121/TEZ/D-IVA (Drug)
Sequence 2
Participants will receive a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods.
Intervention: VX-121/TEZ/D-IVA (Drug)
Outcomes
Primary Outcomes
Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA
Time Frame: Pre-dose up to 288 hours Post-dose
Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVA
Time Frame: Pre-dose up to 288 hours Post-dose
Secondary Outcomes
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to Day 28)