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Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01737996
First received: November 26, 2012
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.

Condition Intervention Phase
Healthy
Drug: BI 207127 + faldaprevir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Healthy Subjects With AEs (Multiple Rising Dose Part) [ Time Frame: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration) ] [ Designated as safety issue: No ]
    Number of healthy subjects with any adverse event (AE) during the on-treatment period.

  • AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning. ] [ Designated as safety issue: No ]
    Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.

  • Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]
    Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.

  • C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]
    Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    CD 6168 is a major metabolite of Deleobuvir.


  • Cmax and Cmax,ss of CD 6168 (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.

    CD 6168 is a major metabolite of Deleobuvir.


  • C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    CD 6168 is a major metabolite of Deleobuvir.


  • AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    BI 208333 is a major metabolite of Deleobuvir.


  • Cmax and Cmax,ss of BI 208333 (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.

    BI 208333 is a major metabolite of Deleobuvir.


  • C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    BI 208333 is a major metabolite of Deleobuvir.


  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    CD 6168 acylglucuronide is a metabolite of Deleobuvir.


  • Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.

    CD 6168 acylglucuronide is a metabolite of Deleobuvir.


  • C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    CD 6168 acylglucuronide is a metabolite of Deleobuvir.


  • AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.

  • Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part) [ Time Frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning. ] [ Designated as safety issue: No ]
    Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.


Secondary Outcome Measures:
  • AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

  • Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]
    Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.

  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

    CD 6168 is a major metabolite of Deleobuvir.


  • Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.

    CD 6168 is a major metabolite of Deleobuvir.


  • AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

    BI 208333 is a major metabolite of Deleobuvir.


  • Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.

    BI 208333 is a major metabolite of Deleobuvir.


  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

    CD 6168 acylglucuronide is a metabolite of Deleobuvir.


  • Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part) [ Time Frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. ] [ Designated as safety issue: No ]

    Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.

    CD 6168 acylglucuronide is a metabolite of Deleobuvir.



Enrollment: 32
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir
Drug: BI 207127 + faldaprevir
fixed dose combination

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737996

Locations
Germany
1241.35.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01737996     History of Changes
Other Study ID Numbers: 1241.35  2012-003697-10 
Study First Received: November 26, 2012
Results First Received: January 21, 2016
Last Updated: March 10, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 27, 2016