A phase 1, two-part, randomized, open-label study to evaluate the relative bioavailability and food effect of test formulations of VX-152 and Ivacaftor in healthy subjects
Completed
- Conditions
- Cystic Fibrosis10038686
- Registration Number
- NL-OMON43101
- Lead Sponsor
- Vertex Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
healthy male and female volunteers
18-55 yrs, inclusive
18.0-31.0 kg/m2, inclusive
non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. The volunteers does not have a history of hemolysis and the blood analyses at screening are not indicative of G6PD deficiency or chronic hemolysis. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 56 days from the start of the study. In case of donating more than 0.5 liters of blood in the 56 days 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 relative bioavailability of 3 test formulations of VX-152<br /><br>relative to suspension in healthy subjects<br /><br><br /><br>Part B:<br /><br>To evaluate the relative bioavailability of a test formulation of ivacaftor<br /><br>relative to a tablet formulation in healthy subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A:<br /><br>- To evaluate the safety and tolerability of single doses of 3 test<br /><br>formulations of VX-152 administered to healthy subjects<br /><br>- To evaluate the effect of food on the pharmacokinetics (PK) of a test<br /><br>formulation of VX-152 when administered in fed relative to fasted conditions in<br /><br>healthy subjects<br /><br><br /><br>Part B:<br /><br>- To evaluate the safety and tolerability of single doses of a test formulation<br /><br>of ivacaftor administered to healthy subjects<br /><br>- To evaluate the effect of food on the PK of a test formulation of ivacaftor<br /><br>when administered in fed relative to fasted conditions in healthy subjects</p><br>