A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo; Drug: VX-548; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05818852

VX21-548-009

Details and patient eligibility

About

The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.

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: 72 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)
• A total body weight greater than (>) 50 kilogram (kg)

Key Exclusion Criteria:

• History of febrile illness within 5 days before the first dose of study drug
• Any condition possibly affecting drug absorption
• Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups

Group 1

Experimental group

Description:

Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.

Treatment:

Drug: Moxifloxacin Placebo

Drug: VX-548

Drug: VX-548 Placebo

Group 2A

Active Comparator group

Description:

Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.

Treatment:

Drug: Moxifloxacin Placebo

Drug: VX-548 Placebo

Drug: Moxifloxacin

Group 2B

Active Comparator group

Description:

Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.

Treatment:

Drug: Moxifloxacin Placebo

Drug: VX-548 Placebo

Drug: Moxifloxacin