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Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Dates, Status, Enrollment

Verified by: Boehringer Ingelheim Pharmaceuticals, May 2013

First Received: October 15, 2012 | Last Updated: May 15, 2013

Phase: Phase 1 | Start Date: October 2012

Overall Status: Completed | Estimated Enrollment: 24

Brief Summary

Skip to Participation Criteria

Official Title: "Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)"

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2012

Interventions Used in this Clinical Trial

  • Drug: Ketoconazole
    • Ketoconazole 400 mg / day
  • Drug: BI 144807
    • BI144807 oral solution, intermediate dose
  • Drug: BI 144807
    • BI144807 oral solution, intermediate dose

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: BI 144807
    • subjects receive an oral single dose of BI 144807
  • Experimental: BI 144807 plus Ketoconazole
    • subjects receive bid ketoconazole plus an oral single dose of BI 144807

Outcome Measures for this Clinical Trial

Primary Measures

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
    • Time Frame: 0 to 48 hours after administration
      Safety Issue?: No
  • Maximum measured concentration of the analyte in plasma
    • Time Frame: 0 to 48 hours after administration
      Safety Issue?: No

Secondary Measures

  • 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: 0 to 48 hours after administration
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. healthy male subjects

Exclusion Criteria

1. any relevant deviation from healthy conditions

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Boehringer Ingelheim Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Pharmaceuticals