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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
ClinicalTrials.gov Identifier:
NCT01707940
First received: October 15, 2012
Last updated: May 15, 2013
Last verified: May 2013
  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:


Further study details as provided by Boehringer Ingelheim:

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
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: NCT01707940

Locations
Germany
1313.7.1 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
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
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014