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

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ClinicalTrials.gov Identifier: NCT01707940
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Ketoconazole Drug: BI 144807 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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 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)
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. Maximum measured concentration of the analyte in plasma [ Time Frame: 0 to 48 hours after administration ]

Secondary Outcome Measures :
  1. 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 ]


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:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions


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): NCT01707940


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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01707940    
Other Study ID Numbers: 1313.7
2012-003225-21 ( EudraCT Number: EudraCT )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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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