A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-983 Followed by an Open-Label, Randomized, Crossover Study to Estimate the Effect of Steady State Administration of VX-983 on the Pharmacokinetics of a Single, Oral Dose of Midazolam in Healthy Adult Subjects

Completed

• Conditions: Cystic fibrosis; 10038686

• Registration Number: NL-OMON37286
• 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: 92

Inclusion Criteria

healthy male and female subjects
18-55 yrs, inclusive
BMI: 18.0-31.0 kg/m2, inclusive

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>Safety and tolerability will be based on the assessment of adverse events,<br /><br>clinically significant laboratory test results, 12-lead lectrocardiograms<br /><br>(ECGs), and vital signs.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Parts A and B: PK parameters will be calculated for VX-983 and its metabolites<br /><br>(if possible) from plasma and urine samples collected in this<br /><br>study<br /><br>Part C: PK parameters will be calculated for midazolam, 1-OHmidazolam, VX-983,<br /><br>and its metabolites (if possible) from plasma samples collected in this study</p><br>