Phase 1 Completed N=48 Randomized Single-blind Treatment

Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.

Healthy

Source: ClinicalTrials.gov NCT01965431 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcomePrimary: 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

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.