Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Faldaprevir

Drug: Tacrolimus

Drug: Cyclosporine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02016625

1241.61

2013-003435-30 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus

Enrollment

32 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males or females subjects
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

Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged clinically relevant by the investigator.
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