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Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01189175
First received: August 25, 2010
Last updated: October 31, 2013
Last verified: October 2013

August 25, 2010
October 31, 2013
August 2010
September 2010   (final data collection date for primary outcome measure)
  • AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) of BI 113823 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Relative bioavailability is primarily to be investigated on the basis of the pharmacokinetic parameters (AUC and Cmax) of BI 113823: [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01189175 on ClinicalTrials.gov Archive Site
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in physical examination [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in vital signs [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in ECG [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in laboratory tests [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Assessment of tolerability by the investigator [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24) [ Time Frame: visit 2, day 1 and visit 4 day 1 ] [ Designated as safety issue: No ]
  • fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24 [ Time Frame: visit 2, day 1 and visit 4 day 1 ] [ Designated as safety issue: No ]
  • CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24) [ Time Frame: visit 2, day 1 and visit 4 day 1 ] [ Designated as safety issue: No ]
  • Additional pharmacokinetic parameters will be assessed for BI 113823 as secondary endpoints [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability (physical examination, ECG, vital signs...) [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823
Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)

The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: BI 113823 + Ketokonazole
    5 days ketokonazole with single oral dose of BI 113823 on day 3
  • Drug: BI 113823
    single oral dose
  • Experimental: BI 113823
    single oral dose per subject
    Intervention: Drug: BI 113823
  • Experimental: BI 113823 + Ketokonazole
    after wash-out 5 days ketokonazole with BI 113823 on day 3
    Intervention: Drug: BI 113823 + Ketokonazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Not Provided
September 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

healthy male subjects

Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01189175
1272.5, 2010-018542-31
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

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