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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01707940
First received: October 15, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Ketoconazole
Drug: BI 144807
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma [ Time Frame: 0 to 48 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 144807
subjects receive an oral single dose of BI 144807
 Drug: BI 144807
BI144807 oral solution, intermediate dose
Experimental: BI 144807 plus Ketoconazole
subjects receive bid ketoconazole plus an oral single dose of BI 144807
 Drug: Ketoconazole
Ketoconazole 400 mg / day
Drug: BI 144807
BI144807 oral solution, intermediate dose

  Eligibility

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

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707940

Locations
Germany
1313.7.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01707940     History of Changes
Other Study ID Numbers: 1313.7, 2012-003225-21
Study First Received: October 15, 2012
Last Updated: May 15, 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 May 21, 2013