An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants

• Sponsor: Vertex Pharmaceuticals Incorporated (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05867147
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 1.2
• Patients Per Site Per Month: 47.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: Vanzacaftor; Drug: Vanzacaftor Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo	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: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Thorough QT/QTc Study of Vanzacaftor Monotherapy in Healthy Subjects
• Actual Study Start Date: Apr 26, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points.	Drug: Vanzacaftor; Tablets for oral administration.; Drug: Vanzacaftor Placebo; Placebo for oral administration.; Drug: Moxifloxacin Placebo; Tablets for oral administration.
Active Comparator: Group 2A Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points.	Drug: Vanzacaftor Placebo; Placebo for oral administration.; Drug: Moxifloxacin; Tablets for oral administration.; Drug: Moxifloxacin Placebo; Tablets for oral administration.
Active Comparator: Group 2B Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.	Drug: Vanzacaftor Placebo; Placebo for oral administration.; Drug: Moxifloxacin; Tablets for oral administration.; Drug: Moxifloxacin 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 23]

Secondary Outcome Measures

1. Change in Heart Rate (HR) [From Baseline up to Day 23]

2. Change in PR interval, segment [From Baseline up to Day 23]

3. Change in QRS duration [From Baseline up to Day 23]

4. Placebo-corrected Change in QTcF [From Baseline up to Day 23]

5. Placebo-corrected Change in HR [From Baseline up to Day 23]

6. Placebo-corrected Change in PR interval [From Baseline up to Day 23]

7. Placebo-corrected Change in QRS duration [From Baseline up to Day 23]

8. Number of Outliers for QTcF [From Baseline up to Day 23]

9. Number of Outliers for HR [From Baseline up to Day 23]

10. Number of Outliers for PR interval [From Baseline up to Day 23]

11. Number of Outliers for QRS duration [From Baseline up to Day 23]

12. Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence [From Baseline up to Day 23]

13. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Day -2 up to Day 38]

14. Maximum Observed Plasma Concentration (Cmax) of VNZ [Days 11 and 21]

15. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ [Days 11 and 21]

16. Time Taken for VNZ to Reach Maximum Concentration (tmax) [Days 11 and 21]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 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), both inclusive

• Male and female participants of age 18 to 45 years, both inclusive

• Serum potassium, calcium, and magnesium values within normal ranges

Key Exclusion Criteria:

• Median QTcF>450 msec on triplicate 12-lead ECGs

• History of conduction abnormalities

Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion - Tempe	Tempe	Arizona	United States	85283

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: NCT05867147
• Other Study ID Numbers: VX22-121-013
• First Posted: May 19, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 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: Cystic Fibrosis; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of May 19, 2023