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

NCT06312787 | Completed Phase 1 FDA Drug

• 1 other identifier: VX23-118-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of VX-118

  Pre-dose up to 192 hours Post-dose

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

  Pre-dose up to 192 hours Post-dose

Secondary Outcomes (1)

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

  Day 1 up to Day 27

Study Arms (3)

Sequence 1

EXPERIMENTAL

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.

Drug: VX-118

Sequence 2

EXPERIMENTAL

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.

Drug: VX-118

Sequence 3

EXPERIMENTAL

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.

Drug: VX-118

Interventions

VX-118 DRUG

Tablets and Suspension for Oral Administration

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 2, 2024
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)