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Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

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ClinicalTrials.gov Identifier: NCT01795937
Recruitment Status : Completed
First Posted : February 21, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 20, 2013
First Posted Date  ICMJE February 21, 2013
Results First Submitted Date  ICMJE July 3, 2015
Results First Posted Date  ICMJE August 3, 2015
Last Update Posted Date August 3, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • AUCτ,ss (Itraconazole Part) [ Time Frame: -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) [ Time Frame: -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) [ Time Frame: -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) [ Time Frame: -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) [ Time Frame: -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 [ Time Frame: -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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval) for faldaprevir [ Time Frame: up to 6 days ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over the dosing interval) for faldaprevir [ Time Frame: up to 6 days ]
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration) for atorvastatin or rosuvastatin [ Time Frame: up to 3 days ]
  • Cmax (maximum measured concentration of the analyte in plasma) for atorvastatin and rosuvastatin [ Time Frame: up to 3 days ]
Change History Complete list of historical versions of study NCT01795937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • AUCτ,ss of Faldaprevir (Statins Part) [ Time Frame: -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.
  • Cmax,ss of Faldaprevir (Statins Part) [ Time Frame: -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.
  • AUC0-tz of Atorvastatin [ Time Frame: -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 [ Time Frame: -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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval t) for faldaprevir [ Time Frame: up to 3 days ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over the dosing interval) for faldaprevir [ Time Frame: up to 3 days ]
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for atorvastatin or rosuvastatin [ Time Frame: up to 3 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Official Title  ICMJE Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin in Healthy Male and Female Subjects (Open-label, Fixed-sequence)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Itraconazole
    twice daily
  • Drug: Atorvastatin
    single dose
  • Drug: Faldaprevir
    once daily
  • Drug: Rosuvastatin
    single dose
Study Arms  ICMJE
  • Experimental: Part 1: Faldaprevir + Itraconazole
    Interaction of Faldaprevir and Itraconazole
    Interventions:
    • Drug: Itraconazole
    • Drug: Faldaprevir
  • Experimental: Part 2:Faldaprevir+Rosuvastatin+Atorvast
    Interaction of Faldaprevir, Rosuvastatin and Atorvastatin
    Interventions:
    • Drug: Atorvastatin
    • Drug: Faldaprevir
    • Drug: Rosuvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2013)
51
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2013)
54
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01795937
Other Study ID Numbers  ICMJE 1220.61
2012-005518-20 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP