A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: VX-993

Study type: Interventional

Funder types: Industry

Identifiers

NCT06508762

VX24-993-005

Details and patient eligibility

About

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-993 in healthy adult participants.

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: 24 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 meter square (kg/m^2), inclusive
• A total body weight of more than (>) 50 kg
• Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

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, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 1 patient group

VX-993

Experimental group

Description:

Participants will be randomized to receive VX-993 in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two VX-993 formulations and the effect of food on the pharmacokinetics of VX-993.

Treatment:

Drug: VX-993