Clinical trial NCT02016625: Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus
Official title: Investigation of Potential Drug-drug Interactions Between Faldaprevir and Immunosuppressants (Cyclosporine and Tacrolimus) in Healthy Male and Female Subjects (Open-label, Fixed-sequence Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: up to 168 hours (details in description)
measure: AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)
timeFrame: up to 168 hours (details in description)
measure: Cmax (Maximum Measured Concentration of the Cyclo in Plasma)
timeFrame: up to 168 hours (details in description)
measure: Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)
timeFrame: up to 168 hours (details in description)
measure: C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval)
timeFrame: up to 168 hours (details in description)
measure: AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)
timeFrame: up to 168 hours (details in description)
measure: AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: up to 192 hours (details in description)
measure: AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)
timeFrame: up to 192 hours (details in description)
measure: Cmax (Maximum Measured Concentration of the Tac in Plasma)
timeFrame: up to 192 hours (details in description)
measure: Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)
timeFrame: up to 168 hours (details in description)
measure: C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval)
timeFrame: up to 168 hours (details in description)
measure: AUC τ,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)
timeFrame: up to 168 hours (details in description)
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: 1241.61.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: