A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, 4-Period Crossover ECG Study to Evaluate the Effect of VX 509 on QT/QTc Interval in Healthy Adult Subjects

Completed

• Conditions: autoimmune disorders; Rheumatoid arthritis; 10003816

• Registration Number: NL-OMON37134
• Lead Sponsor: Vertex Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

healthy male and female subjects
18-55 yrs, inclusive (part A)
18-45 yrs, inclusive (part B)
BMI: 18.0-31.0 kg/m2, inclusive
non-smoking

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 doses of 750 mg qd of<br /><br>VX-509 in healthy subjects.<br /><br>Part B:<br /><br>- To evaluate the effect of 200 mg qd (therapeutic) and 600 or 750 mg qd<br /><br>(supratherapeutic dose; to be determined from Part A) of VX-509, versus placebo<br /><br>on the QT/QTc interval in healthy subjects. </p><br>