Phase 1
Completed N=32
Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus
Healthy
Source: ClinicalTrials.gov NCT02016625 ↗
Enrolled (actual)
32
Serious AEs
1.1%
Results posted
Apr 2016
Primary outcomePrimary: AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity) — 672; 732 ng*h/mL — p=0.0033
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
672; 732 | 0.0033 sig |
| PRIMARY 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) |
635; 685 | 0.0019 sig |
| PRIMARY Cmax (Maximum Measured Concentration of the Cyclo in Plasma) |
172; 164 | 0.0457 sig |
| PRIMARY Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ) |
1740; 2470 | 0.8122 |
| PRIMARY C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval) |
619; 723 | 0.0650 |
| PRIMARY AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ) |
24600; 30600 | 0.4181 |
| PRIMARY AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
16.0; 20.4 | 0.6207 |
| PRIMARY 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) |
11.1; 15.3 | 0.8592 |
| PRIMARY Cmax (Maximum Measured Concentration of the Tac in Plasma) |
1.14; 1.13 | 0.0269 sig |
| PRIMARY Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ) |
3120; 2930 | 0.0493 sig |
| PRIMARY C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval) |
904; 900 | 0.0000 sig |
| PRIMARY 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) |
40300; 38700 | 0.0008 sig |
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
Data sourced from ClinicalTrials.gov (NCT02016625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.