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

Study Overview
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Brief Summary
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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
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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.).

Official Title
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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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: VX-121/TEZ/D-IVA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>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. | Drug: VX-121/TEZ/D-IVA<br>* FDC tablet for oral administration.<br>* Other names: VX-121/tezacaftor/deutivacaftor;|
| Experimental: Sequence 2<br>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. | Drug: VX-121/TEZ/D-IVA<br>* FDC tablet for oral administration.<br>* Other names: VX-121/tezacaftor/deutivacaftor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVA |  | Pre-dose up to 288 hours Post-dose | 
| Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA |  | Pre-dose up to 288 hours Post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 28 |