Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Itraconazole; Drug: Atorvastatin; Drug: Faldaprevir; Drug: Rosuvastatin

• Registration Number: NCT01795937
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-21
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1: Faldaprevir + Itraconazole	Itraconazole	Interaction of Faldaprevir and Itraconazole
Part 1: Faldaprevir + Itraconazole	Faldaprevir	Interaction of Faldaprevir and Itraconazole
Part 2:Faldaprevir+Rosuvastatin+Atorvast	Atorvastatin	Interaction of Faldaprevir, Rosuvastatin and Atorvastatin
Part 2:Faldaprevir+Rosuvastatin+Atorvast	Rosuvastatin	Interaction of Faldaprevir, Rosuvastatin and Atorvastatin
Part 2:Faldaprevir+Rosuvastatin+Atorvast	Faldaprevir	Interaction of Faldaprevir, Rosuvastatin and Atorvastatin

Primary Outcome Measures

Name	Time	Method
AUCτ,ss (Itraconazole Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods	Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax,ss (Itraconazole Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.	Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
AUC0-∞ of Atorvastatin (Statins Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax of Atorvastatin (Statins Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods	Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
AUC0-∞ of Rosuvastatin (Statins Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax of Rosuvastatin	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods	Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Secondary Outcome Measures

Name	Time	Method
Cmax,ss of Faldaprevir (Statins Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.	Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.
AUCτ,ss of Faldaprevir (Statins Part)	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.	Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.
AUC0-tz of Atorvastatin	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods	Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
AUC0-tz of Rosuvastatin	-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods	Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Trial Locations

Locations (1)

1220.61.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany