Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: BI 113608 (Drug); BI 113608 (Drug); BI 113608 (Drug); Ketoconazole (Drug); Voriconazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The primary objective of this trial is to investigate the relative bioavailability of a
single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady
state. The assessment of safety and tolerability of BI 113608 administered alone and upon
co-administration will be an additional objective of this trial.
Clinical Details
Official title: Relative Bioavailability of Single Oral Dose of BI 113608 When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole or Voriconazole in Healthy Male Subjects (an Open-label, Randomised, Three-period Cross-over Trial)
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)Cmax (maximum measured concentration of the analyte in plasma) Incidence of Adverse Events
Secondary outcome: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)tmax (time from dosing to maximum measured concentration of the analyte in plasma) t1/2 (terminal half-life of the analyte in plasma)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions.
Locations and Contacts
1314.7.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany
Additional Information
Starting date: January 2013
Last updated: October 31, 2013
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