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

NCT05818852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-03-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2023-06-12
Completion
2023-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818852 on ClinicalTrials.gov