Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus
NCT ID: NCT02016625
Last Updated: 2016-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2013-12-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1 Cyclosporine + Faldaprevir
Faldaprevir
Cyclosporine
2 Tacrolimus + Faldaprevir
Faldaprevir
Tacrolimus
Interventions
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Faldaprevir
Faldaprevir
Cyclosporine
Tacrolimus
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 50 years (incl.)
* Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study
Exclusion Criteria
* Systolic blood pressure (BP) less than 100 mmHg and more than 140 mmHg.
* Diastolic BP less than 60 mmHg and more than 90 mmHg.
* Pulse rate (PR) less than 50 bpm and more than 90 bpm.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Positive QuantiFERON-TB Gold In-Tube
18 Years
50 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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1241.61.1 Boehringer Ingelheim Investigational Site
Mannheim, , Germany
Countries
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Other Identifiers
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2013-003435-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1241.61
Identifier Type: -
Identifier Source: org_study_id
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