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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:
ClinicalTrials.gov Identifier:
NCT01189175
First Posted: August 26, 2010
Last Update Posted: November 1, 2013
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.
Information provided by:
Boehringer Ingelheim
  Purpose
The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Condition Intervention Phase
Healthy Drug: BI 113823 + Ketokonazole Drug: BI 113823 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]
  • Cmax (maximum measured concentration of the analyte in plasma) of BI 113823 [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • 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 ]
  • Number of participants with clinically significant changes in physical examination [ Time Frame: up to 24 days ]
  • Number of participants with clinically significant changes in vital signs [ Time Frame: up to 24 days ]
  • Number of participants with clinically significant changes in ECG [ Time Frame: up to 24 days ]
  • Number of participants with clinically significant changes in laboratory tests [ Time Frame: up to 24 days ]
  • Occurrence of adverse events [ Time Frame: up to 24 days ]
  • Assessment of tolerability by the investigator [ Time Frame: up to 24 days ]
  • AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: 2 weeks ]
  • 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 ]
  • tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: 2 weeks ]
  • λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma [ Time Frame: 2 weeks ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 2 weeks ]
  • MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: 2 weeks ]
  • CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: 2 weeks ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: 2 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 16
Study Start Date: August 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 113823
single oral dose per subject
Drug: BI 113823
single oral dose
Experimental: BI 113823 + Ketokonazole
after wash-out 5 days ketokonazole with BI 113823 on day 3
Drug: BI 113823 + Ketokonazole
5 days ketokonazole with single oral dose of BI 113823 on day 3

  Eligibility

Information from the National Library of Medicine

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

Inclusion criteria:

healthy male subjects

  Contacts and Locations
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): NCT01189175


Locations
Germany
1272.5.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01189175     History of Changes
Other Study ID Numbers: 1272.5
2010-018542-31 ( EudraCT Number: EudraCT )
First Submitted: August 25, 2010
First Posted: August 26, 2010
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors