Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01737996
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: BI 207127 + faldaprevir Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) ]
    Number of healthy subjects with any adverse event (AE) during the on-treatment period.

  2. 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. ]
    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.

  3. 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. ]
    Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.

  4. 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. ]
    Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

  5. 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. ]

    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.


  6. 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. ]

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

    CD 6168 is a major metabolite of Deleobuvir.


  7. 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. ]

    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.


  8. 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. ]

    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.


  9. 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. ]

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

    BI 208333 is a major metabolite of Deleobuvir.


  10. 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. ]

    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.


  11. 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. ]

    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.


  12. 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. ]

    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.


  13. 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. ]

    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.


  14. 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. ]
    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.

  15. 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. ]
    Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.

  3. 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. ]

    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.


  4. 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. ]

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

    CD 6168 is a major metabolite of Deleobuvir.


  5. 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. ]

    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.


  6. 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. ]

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

    BI 208333 is a major metabolite of Deleobuvir.


  7. 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. ]

    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.


  8. 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. ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737996


Locations
Layout table for location information
Germany
1241.35.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01737996    
Other Study ID Numbers: 1241.35
2012-003697-10 ( EudraCT Number: EudraCT )
First Posted: November 30, 2012    Key Record Dates
Results First Posted: April 8, 2016
Last Update Posted: April 8, 2016
Last Verified: March 2016