A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of VX-661 on the QT/QTc Interval in Healthy Subjects

Completed

Conditions: cystic fibrosis
10038686

Registration Number: NL-OMON42529

Lead Sponsor: Vertex Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

healthy male or female
18-45 y, incl.
BMI 18.0 - 30.0

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A:<br /><br>To evaluate the safety and tolerability of multiple ascending doses of VX-661<br /><br>in healthy subjects.<br /><br><br /><br>Part B:<br /><br>To evaluate the effects of therapeutic and supratherapeutic doses of VX-661<br /><br>compared with placebo on the QTc interval in healthy subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A:<br /><br>To evaluate the PK of VX-661 and its metabolites, M1-661 and M2-661, following<br /><br>multiple ascending doses of VX-661 in healthy subjects<br /><br><br /><br>Part B<br /><br>To evaluate assay sensitivity (i.e., to evaluate the effect of moxifloxacin on<br /><br>the QTc interval in healthy subjects)<br /><br>To assess the effects of VX-661 compared with placebo on other<br /><br>electrocardiogram (ECG) parameters (heart rate [HR], PR, and QRS intervals<br /><br>and T-wave morphology) in healthy subjects<br /><br>To determine the VX-661, M1-661, and M2-661 plasma concentration-effect<br /><br>relationship for the QTc interval and the magnitude of the relationship, if any<br /><br>exist<br /><br>To evaluate the PK of VX-661, M1-661, and M2-661 in healthy subjects<br /><br>To evaluate the safety and tolerability of VX-661 in healthy subjects</p><br>