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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: Vanzacaftor Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo; Drug: Vanzacaftor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05867147

VX22-121-013

Details and patient eligibility

About

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.

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: 56 patients

Sex: All

Ages: 18 to 45 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), 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Vanzacaftor

Drug: Moxifloxacin Placebo

Drug: Vanzacaftor Placebo

Group 2A

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Moxifloxacin Placebo

Drug: Vanzacaftor Placebo

Group 2B

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Moxifloxacin Placebo

Drug: Vanzacaftor Placebo