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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

healthy male subjects

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01189175     History of Changes
Other Study ID Numbers: 1272.5, 2010-018542-31
Study First Received: August 25, 2010
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014