Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

NCT01795937 | Completed Phase 1 Results

• 2 other identifiers: 1220.612012-005518-20
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• AUCτ,ss (Itraconazole Part)

  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.

  -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

• Cmax,ss (Itraconazole Part)

  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.

  -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.

• AUC0-∞ of Atorvastatin (Statins Part)

  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.

  -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.

• Cmax of Atorvastatin (Statins Part)

  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.

  -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

• AUC0-∞ of Rosuvastatin (Statins Part)

  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.

  -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

• Cmax of Rosuvastatin

  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.

  -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

Secondary Outcomes (4)

• 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.

• 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.

• 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

• 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

Study Arms (2)

Part 1: Faldaprevir + Itraconazole

EXPERIMENTAL

Interaction of Faldaprevir and Itraconazole

Drug: Itraconazole; Drug: Faldaprevir

Part 2:Faldaprevir+Rosuvastatin+Atorvast

EXPERIMENTAL

Interaction of Faldaprevir, Rosuvastatin and Atorvastatin

Drug: Atorvastatin; Drug: Faldaprevir; Drug: Rosuvastatin

Interventions

Itraconazole DRUG

twice daily

Part 1: Faldaprevir + Itraconazole

Atorvastatin DRUG

single dose

Part 2:Faldaprevir+Rosuvastatin+Atorvast

Faldaprevir DRUG

once daily

Part 2:Faldaprevir+Rosuvastatin+Atorvast

Rosuvastatin DRUG

single dose

Part 2:Faldaprevir+Rosuvastatin+Atorvast

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male and female subjects

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1220.61.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Interventions

Itraconazole; Atorvastatin; faldaprevir; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 21, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 3, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-07

Locations

DE (1)