A Randomized, Placebo- and Active-Controlled, Double-Blind, 4-way Crossover Design, Thorough ECG Study of VX-770 in Healthy Adult Subjects
Completed
- Conditions
- 10027664Cystic Fibrosis
- Registration Number
- NL-OMON34380
- Lead Sponsor
- Vertex Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Part A
Male
Age 18-45
Non-smoking;Part B
Male and females
Age 18-45
Non-smoking
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating any blood or significant loss of blood within 60 days of the start of drug dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A<br /><br>Safety and tolerability of VX 770 as measured by standard 12 lead<br /><br>electrocardiograms (ECGs), adverse events, physical examinations, vital signs,<br /><br>and clinically significant laboratory assessments.<br /><br><br /><br>Part B<br /><br>Time-matched, baseline-adjusted, placebo-subtracted QTcF interval obtained from<br /><br>continuous 12-lead ECG recording.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A<br /><br>- PK parameters of VX 770 and metabolites M1 and M6 in plasma<br /><br><br /><br>Part B<br /><br>- Time-matched, baseline-adjusted, placebo-subtracted QT interval obtained from<br /><br>continuous ECG recording<br /><br>- Time-matched, baseline-adjusted, placebo-subtracted QTcB interval obtained<br /><br>from continuous ECG recording<br /><br>- PK parameters of VX 770 and its metabolites in plasma<br /><br>- Safety of VX 770 as measured by standard 12 lead ECGs, adverse events,<br /><br>physical examinations, vital signs, and clinically significant laboratory<br /><br>assessments.</p><br>