A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

Vertex Pharmaceuticals Incorporated34 enrolled

Overview

The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

VNZ/TEZ/D-IVADRUG

FDC tablet for oral administration.

VNZ/TEZ/D-IVADRUG

FDC granules for oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 within 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 or within 90 days after the last dose of the study drug Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

Celerion, Inc.

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA

Time frame: Pre-dose up to 288 hours Post-dose

Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA

Time frame: Pre-dose up to 384 hours Post-dose

Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

Time frame: Pre-dose up to 288 hours Post-dose

Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

Time frame: Pre-dose up to 384 hours Post-dose

Secondary Outcomes

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Day 42

Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Day 36

Data from ClinicalTrials.gov

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