A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 Alone and in Combination with VX-661/Ivacaftor, and Bioavailability and Food Effect of VX-440 in Healthy Adult Subjects

Completed

• Conditions: cystic fibrosis; 10038686

• Registration Number: NL-OMON43882
• Lead Sponsor: Vertex Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

healthy male or female
18-55 y, incl.
BMI 18.0 - 31.0, and a total body weight >50 kg

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 single oral ascending doses of VX<br /><br>440 administered to healthy male and female<br /><br>subjects<br /><br><br /><br>Part B<br /><br>To evaluate the safety and tolerability of multiple oral ascending doses of VX<br /><br>440 administered for 14 days to healthy<br /><br>male and female subjects<br /><br><br /><br>Part C<br /><br>To evaluate the safety and tolerability of multiple oral ascending doses of VX<br /><br>440 administered in combination with VX<br /><br>661/ivacaftor (triple combination [TC]) administered for 13 days to healthy<br /><br>male and female subjects<br /><br><br /><br>Part D<br /><br>To evaluate the absolute bioavailability (BA) of oral VX 440 and the clearance<br /><br>of VX 440 administered as an isotopicallylabeled<br /><br>intravenous (IV) microdose to healthy male and female subjects</p><br>