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Trial record 11 of 50 for:    BI 201335 OR faldaprevir

Pharmacokinetics of Faldaprevir of Soft Capsule

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ClinicalTrials.gov Identifier: NCT01821937
Recruitment Status : Completed
First Posted : April 1, 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 March 25, 2013
First Posted Date  ICMJE April 1, 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 March 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Cmax,ss (After Multiple Dosing) [ Time Frame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir ]
    C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.
  • AUC(Tau,ss) (After Multiple Dosing) [ Time Frame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir ]
    AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • Single dose:AUC,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval after administration of the first dose) [ Time Frame: up to 8 weeks ]
  • Single dose:AUC0- (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 8 weeks ]
  • Single dose:AUCtz- (the percentage of the AUC 0- that is obtained by extrapolation) [ Time Frame: up to 8 weeks ]
  • Single dose:z (terminal rate constant in plasma) [ Time Frame: up to 8 weeks ]
  • Single dose: t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 8 weeks ]
  • Single dose: tz (time of last measurable concentration of the analyte in plasma [ Time Frame: up to 8 weeks ]
  • Single dose: MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: up to 8 weeks ]
  • Single dose:CL/F (apparent clearance of the analyte in plasma following po administration) [ Time Frame: up to 8 weeks ]
  • Single dose:Vz/F (apparent volume of distribution during the terminal phase z following an po administration) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval ) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:z,ss (terminal rate constant in plasma at steady state) [ Time Frame: up to 8 weeks ]
  • Multiple Dose: MRTpo,ss (mean residence time of the analyte in the body at steady state after po administration) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:CL/F,ss (apparent clearance of the analyte in the plasma at steady state following po multiple dose administration) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:Vz/F,ss (apparent volume of distribution during the terminal phase z at steady state following po administration) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered) [ Time Frame: up to 8 weeks ]
  • Multiple Dose: tmax(,N) (time from last dosing to maximum concentration of the analyte in plasma after administration of N doses) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:In addition, the accumulation ratios (RA, Cmax, based on Cmax; RA, AUC, based on AUC0-) and the linearity index (LI) of the analyte in plasma following ten doses in healthy volunteers over a uniform dosing interval will be calculated. [ Time Frame: up to 8 weeks ]
  • Multiple Dose: Cmax,ss(maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval ) [ Time Frame: up to 8 weeks ]
  • Multiple Dose: AUC,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval ) [ Time Frame: up to 8 weeks ]
  • Single dose: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 8 weeks ]
  • Single Dose:AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) (if applicable) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:t1/2,ss (terminal half-life of the analyte in plasma at steady state) (if applicable) [ Time Frame: up to 8 weeks ]
  • Multiple Dose:tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 8 weeks ]
Change History Complete list of historical versions of study NCT01821937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Cmax (After Single Dosing) [ Time Frame: Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir ]
    Cmax is defined as maximum measured concentration of Faldaprevir in plasma.
  • AUC(0-tz) (After Single Dosing) [ Time Frame: Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir ]
    AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.
  • t(1/2,ss) (After Multiple Dosing) [ Time Frame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir ]
    t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.
  • Tmax,ss (After Multiple Dosing) [ Time Frame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir ]
    tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Faldaprevir of Soft Capsule
Official Title  ICMJE Pharmacokinetics of Single and Multiple Oral Doses of 120 mg and 240 mg BI 201335 in Healthy Chinese Volunteers
Brief Summary The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: faldaprevir(high dose)
    faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order
  • Drug: Faldaprevir(low dose)
    faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order
Study Arms  ICMJE
  • Experimental: faldaprevir(high dose)
    10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
    Intervention: Drug: faldaprevir(high dose)
  • Experimental: Faldaprevir(low dose)
    10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
    Intervention: Drug: Faldaprevir(low dose)
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 17, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2013)
20
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821937
Other Study ID Numbers  ICMJE 1220.52
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