Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 113823; Drug: BI 113823 + Ketokonazole

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1272.5.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

healthy male subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BI 113823; single oral dose per subject	Drug: BI 113823; single oral dose
EXPERIMENTAL: BI 113823 + Ketokonazole; after wash-out 5 days ketokonazole with BI 113823 on day 3	Drug: BI 113823 + Ketokonazole; 5 days ketokonazole with single oral dose of BI 113823 on day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823	2 weeks
Cmax (maximum measured concentration of the analyte in plasma) of BI 113823	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	2 weeks
Number of participants with clinically significant changes in physical examination	up to 24 days
Number of participants with clinically significant changes in vital signs	up to 24 days
Number of participants with clinically significant changes in ECG	up to 24 days
Number of participants with clinically significant changes in laboratory tests	up to 24 days
Occurrence of adverse events	up to 24 days
Assessment of tolerability by the investigator	up to 24 days
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)	2 weeks
AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax	2 weeks
tmax (time from dosing to the maximum concentration of the analyte in plasma)	2 weeks
λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma	2 weeks
t1/2 (terminal half-life of the analyte in plasma)	2 weeks
MRTpo (mean residence time of the analyte in the body after po administration)	2 weeks
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)	2 weeks
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	2 weeks
Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)	visit 2, day 1 and visit 4 day 1
fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24	visit 2, day 1 and visit 4 day 1
CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)	visit 2, day 1 and visit 4 day 1

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (ESTIMATE): August 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 1272.5; 2010-018542-31 (EUDRACT_NUMBER: EudraCT)