Clinical trial NCT01189175: Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823
Official title: Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823


Eligibility criteria: Inclusion criteria:

healthy male subjects

Primary outcomes:
measure: AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823
timeFrame: 2 weeks
measure: Cmax (maximum measured concentration of the analyte in plasma) of BI 113823
timeFrame: 2 weeks
Secondary outcomes:
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: 2 weeks
measure: Number of participants with clinically significant changes in physical examination
timeFrame: up to 24 days
measure: Number of participants with clinically significant changes in vital signs
timeFrame: up to 24 days
measure: Number of participants with clinically significant changes in ECG
timeFrame: up to 24 days
measure: Number of participants with clinically significant changes in laboratory tests
timeFrame: up to 24 days
measure: Occurrence of adverse events
timeFrame: up to 24 days
measure: Assessment of tolerability by the investigator
timeFrame: up to 24 days
measure: AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
timeFrame: 2 weeks
measure: AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax
timeFrame: 2 weeks
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: 2 weeks
measure: λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma
timeFrame: 2 weeks
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: 2 weeks
measure: MRTpo (mean residence time of the analyte in the body after po administration)
timeFrame: 2 weeks
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
timeFrame: 2 weeks
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
timeFrame: 2 weeks
measure: Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)
timeFrame: visit 2, day 1 and visit 4 day 1
measure: fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24
timeFrame: visit 2, day 1 and visit 4 day 1
measure: CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)
timeFrame: visit 2, day 1 and visit 4 day 1
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1272.5.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: