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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Tacrolimus

Criteria

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