A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation

Vertex Pharmaceuticals Incorporated68 enrolled

Overview

The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

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-828DRUG

Tablets for Oral Administration.

VX-828DRUG

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 square meter (kg/m\^2) * A total body weight of more than (\>) 50 Kg * Nonsmoker or ex-smoker for at least 3 months before screening * 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 Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

Celerion - Tempe

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Area Under the Concentration Versus Time Curve from the Time of dosing to the Last Measurable Concentration (AUC0-tlast) of VX-828 in Plasma

Time frame: From Day 1 up to Day 24

Maximum Observed Concentration (Cmax) of VX-828 in Plasma

Time frame: From Day 1 up to Day 24

Secondary Outcomes

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

Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 36)

Data from ClinicalTrials.gov

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