A phase 1, randomized, double-blind, placebo-controlled study evaluating the pharmacokinetics of capsule and tablet formulations of VX-150, including the effects of food and milk, the relative bioavailability of the tablet formulation, and the drug-drug interaction between VX-150 and Midazolam, in healthy adults
Completed
- Conditions
- pijnpain
- Registration Number
- NL-OMON45544
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
- healthy male or femaile 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 90 days before the start of this study or being a blood donor within 60 days from the start of the study. Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug, or any significant loss of blood, as determined by the investigator, within 60 days before the first dose of study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Plasma PK parameter estimates of VRT-1207355 and M5</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Plasma PK parameter estimates of midazolam and 1-hydroxy midazolam<br /><br>- Safety and tolerability based on the incidence and type of AEs, changes from<br /><br>baseline in clinically significant laboratory test results, ECGs (standard and<br /><br>continuous), and vital signs at designated visits</p><br>