NCT05818852

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

A Phase 1, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.).

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	VX-548	Tablets for oral administration.
DRUG	Moxifloxacin	Capsules for oral administration.
DRUG	Moxifloxacin Placebo	Capsules for oral administration.
DRUG	VX-548 Placebo	Tablets for oral administration.

Timeline

• Start date: 2023-04-12
• Primary completion: 2023-06-12
• Completion: 2023-06-28
• First posted: 2023-04-19
• Last updated: 2024-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study