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

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-118 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06312787
• Other study ID #: VX23-118-002
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2024
• Est. completion date: May 4, 2024

Study information

• Verified date: May 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 4, 2024
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• VX-118
Tablets and Suspension for Oral Administration

Locations

Country	Name	City	State
United States	Celerion - Lincoln	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of VX-118		Pre-dose up to 192 hours Post-dose
Primary	Area Under the Concentration Versus Time Curve (AUC) of VX-118		Pre-dose up to 192 hours Post-dose
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)		Day 1 up to Day 27