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

Phase 1

Active, not recruiting

• Conditions: Cystic Fibrosis
• Interventions: Drug: VX-828

• Registration Number: NCT06861413
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-06
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-05-05
• Study Completion: 2025-05-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	VX-828	Participants will be randomized to receive a single dose of VX-828 suspension.
Cohort 2	VX-828	Participants will be randomized to receive a single dose of VX-828 tablets.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve from the Time of dosing to the Last Measurable Concentration (AUC0-tlast) of VX-828 in Plasma	From Day 1 up to Day 24
Maximum Observed Concentration (Cmax) of VX-828 in Plasma	From Day 1 up to Day 24

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 36)

Trial Locations

Locations (1)

Celerion - Tempe; 🇺🇸 Tempe, Arizona, United States