Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
- Conditions
- Healthy
- Interventions
- Drug: BI 207127 placebo
- Registration Number
- NCT01965431
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BI 207127 + Faldaprevir BI 207127 Tablets/capsules Moxifloxacin (Avalox®) Moxifloxacin (Avalox®) Tablets BI 207127 placebo + Faldaprevir placebo BI 207127 placebo Tablets/capsules BI 207127 placebo + Faldaprevir placebo Faldaprevir placebo Tablets/capsules BI 207127 + Faldaprevir Faldaprevir Tablets/capsules
- Primary Outcome Measures
Name Time Method Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated.
QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.
- Secondary Outcome Measures
Name Time Method Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1 Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated.
QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.
Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.
Trial Locations
- Locations (1)
1241.40.1 Boehringer Ingelheim Investigational Site
🇩🇪Ingelheim, Germany
1241.40.1 Boehringer Ingelheim Investigational Site🇩🇪Ingelheim, Germany