Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
NCT ID: NCT01965431
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2013-10-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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BI 207127 + Faldaprevir
Tablets/capsules
BI 207127
Medium dose oral administration
Faldaprevir
Medium dose oral administration
Moxifloxacin (Avalox®)
Tablets
Moxifloxacin (Avalox®)
BI 207127 placebo + Faldaprevir placebo
Tablets/capsules
BI 207127 placebo
Faldaprevir placebo
Interventions
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BI 207127
Medium dose oral administration
BI 207127 placebo
Faldaprevir placebo
Faldaprevir
Medium dose oral administration
Moxifloxacin (Avalox®)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1241.40.1 Boehringer Ingelheim Investigational Site
Ingelheim, , Germany
Countries
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Other Identifiers
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2013-002741-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1241.40
Identifier Type: -
Identifier Source: org_study_id
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