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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: VX-828

Study type: Interventional

Funder types: Industry

Identifiers

NCT06861413

VX25-828-002

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Cohort 1

Active Comparator group

Description:

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

Treatment:

Drug: VX-828

Drug: VX-828

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: VX-828

Drug: VX-828