A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation

Vertex Pharmaceuticals Incorporated15 enrolled

Overview

The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants.

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

VX-118DRUG

Tablets and Suspension 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 * Participants of non-childbearing potential 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 * Hypersensitivity to any component of the investigational drug product Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

Celerion - Lincoln

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of VX-118

Time frame: Pre-dose up to 192 hours Post-dose

Area Under the Concentration Versus Time Curve (AUC) of VX-118

Time frame: Pre-dose up to 192 hours Post-dose

Secondary Outcomes

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

Time frame: Day 1 up to Day 27

Data from ClinicalTrials.gov

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