Phase 1
N=48
Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01965431 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy — -0.47; -8.37 ms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 207127 (Drug); BI 207127 placebo (Drug); Faldaprevir placebo (Drug); Faldaprevir (Drug); Moxifloxacin (Avalox®) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy |
-0.47; -8.37 | — |
| SECONDARY Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment |
14.95; 2.25 | — |
| SECONDARY Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy |
-3.47; -3.64 | — |
| SECONDARY Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy |
-0.68; 3.74 | — |
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
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
- Subjects must be able to understand and comply with study requirements
- Age =18 and =55 years
- BMI range: =18.5 and =29.9 kg/m2
Exclusion criteria
- any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01965431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.