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

NCT06861413 | Completed Phase 1 FDA Drug

• 1 other identifier: VX25-828-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

Participants will be randomized to receive a single dose of VX-828 suspension.

Drug: VX-828

Cohort 2

EXPERIMENTAL

Participants will be randomized to receive a single dose of VX-828 tablets.

Drug: VX-828

Interventions

VX-828 DRUG

Tablets for Oral Administration.

Cohort 2

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 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

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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Tempe

Tempe, Arizona, 85283, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2025
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)