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

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: VX-118

• Registration Number: NCT06312787
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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.

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

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-04-02
• Status Verified: 2024-05
• Primary Completion: 2024-05-04
• Study Completion: 2024-05-04
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	VX-118	Participants will receive a single dose of VX-118 as a suspension in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fed state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Sequence 2	VX-118	Participants will receive a single dose of VX-118 as tablets in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fed state in dosing period 2, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Sequence 3	VX-118	Participants will receive a single dose of VX-118 as tablets in the fed state in dosing period 1, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve (AUC) of VX-118	Pre-dose up to 192 hours Post-dose
Maximum Observed Plasma Concentration (Cmax) of VX-118	Pre-dose up to 192 hours Post-dose

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)	Day 1 up to Day 27

Trial Locations

Locations (1)

Celerion - Lincoln; 🇺🇸 Lincoln, Nebraska, United States