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Trial record 21 of 50 for:    BI 201335 OR faldaprevir

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

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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

Tracking Information
First Submitted Date  ICMJE November 26, 2012
First Posted Date  ICMJE November 30, 2012
Results First Submitted Date  ICMJE January 21, 2016
Results First Posted Date  ICMJE April 8, 2016
Last Update Posted Date April 8, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
  • AUCt (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t) [ Time Frame: up to 2 weeks ]
  • Cmax (maximum measured concentration of the analyte in plasma over a uniform dosing interval t) [ Time Frame: up to 2 weeks ]
  • Ct (concentration of the analyte in plasma at steady state at the end of the dosing interval t) (only for BI 207127 and metabolites) [ Time Frame: up to 2 weeks ]
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ]
  • Ct,ss (concentration of the analyte in plasma at steady state at the end of the dosing interval t) (only for BI 207127 and metabolites) [ Time Frame: up to 2 weeks ]
Change History Complete list of historical versions of study NCT01737996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 2 weeks ]
  • C12 (measured concentration of the analyte in plasma at 12 hours) [ Time Frame: up to 2 weeks ]
  • tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 2 weeks ]
  • 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) [ Time Frame: up to 2 weeks ]
  • AUC0-infinity area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 2 weeks ]
  • %AUCtz-infinity (the percentage of AUC0-infinity obtained by extrapolation) [ Time Frame: up to 2 weeks ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 2 weeks ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ]
  • C12,ss (measured concentration of the analyte in plasma at steady state at 12 hours) [ Time Frame: up to 2 weeks ]
  • tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 2 weeks ]
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 2 weeks ]
  • t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 2 weeks ]
  • RA,Cmax (accumulation ratio based on Cmax,ss) [ Time Frame: up to 2 weeks ]
  • RA,AUC (accumulation ratio based on AUC0-t) [ Time Frame: up to 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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: BI 207127 + faldaprevir
fixed dose combination
Study Arms  ICMJE Experimental: All patients
For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir
Intervention: Drug: BI 207127 + faldaprevir
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: November 28, 2012)
32
Original Estimated Enrollment  ICMJE Same as current
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 NCT01737996
Other Study ID Numbers  ICMJE 1241.35
2012-003697-10 ( 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 March 2016

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