Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers
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)
2 other identifiers
interventional
24
1 country
1
Brief Summary
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Oct 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 16, 2013
May 1, 2013
2 months
October 15, 2012
May 15, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma
0 to 48 hours after administration
Secondary Outcomes (1)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
0 to 48 hours after administration
Study Arms (2)
BI 144807
EXPERIMENTALsubjects receive an oral single dose of BI 144807
BI 144807 plus Ketoconazole
EXPERIMENTALsubjects receive bid ketoconazole plus an oral single dose of BI 144807
Interventions
Eligibility Criteria
You may qualify if:
- \. healthy male subjects
You may not qualify if:
- \. any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1313.7.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 16, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 16, 2013
Record last verified: 2013-05