Clincosm LogoSign in Get a demo

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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05818852
Collaborator
(none)
72
Enrollment
3
Arms
3
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

Drug: VX-548
Tablets for oral administration.

Drug: Moxifloxacin Placebo
Capsules for oral administration.

Drug: VX-548 Placebo
Tablets for oral administration.
Active Comparator: Group 2A

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

Drug: Moxifloxacin
Capsules for oral administration.

Drug: Moxifloxacin Placebo
Capsules for oral administration.

Drug: VX-548 Placebo
Tablets for oral administration.
Active Comparator: Group 2B

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

Drug: Moxifloxacin
Capsules for oral administration.

Drug: Moxifloxacin Placebo
Capsules for oral administration.

Drug: VX-548 Placebo
Tablets for oral administration.

Outcome Measures

Primary Outcome Measures

  1. Change in QT interval corrected by Fridericia's formula (QTcF) [From Baseline up to Day 12]

Secondary Outcome Measures

  1. Change in Heart Rate (HR) [From Baseline up to Day 12]

  2. Change in PR interval, segment [From Baseline up to Day 12]

  3. Change in QRS duration [From Baseline up to Day 12]

  4. Placebo-corrected Change in QTcF [From Baseline up to Day 12]

  5. Placebo-corrected Change in HR [From Baseline up to Day 12]

  6. Placebo-corrected Change in PR interval [From Baseline up to Day 12]

  7. Placebo-corrected Change in QRS duration [From Baseline up to Day 12]

  8. Number of Outliers for QTcF [From Baseline up to Day 12]

  9. Number of Outliers for HR [From Baseline up to Day 12]

  10. Number of Outliers for PR interval [From Baseline up to Day 12]

  11. Number of Outliers for QRS duration [From Baseline up to Day 12]

  12. Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence [From Baseline up to Day 12]

  13. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Day 1 up to Day 26]

  14. Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite [Days 6 and 10: Pre-dose up to 24 hours]

  15. Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite [Days 6 and 10: Pre-dose up to 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT05818852
Other Study ID Numbers:
  • VX21-548-009
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Apr 19, 2023