Olmutinib (BI 1482694) ADME Study
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: [14C]BI 1482694
- Registration Number
- NCT02722161
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of \[14C\]BI 1482694 given to healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]BI 1482694 [14C]BI 1482694 -
- Primary Outcome Measures
Name Time Method Mass balance recovery of [14C]-radioactivity in urine: fe urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) up to 1181 hours (7 weeks) Mass balance recovery of [14C]-radioactivity in faeces: fe faeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) up to 1181 hours (7 weeks)
- Secondary Outcome Measures
Name Time Method AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) for BI 1482694 in plasma up to 72 hours AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) for [14C]-radioactivity in plasma up to 336 hours Cmax (maximum measured concentration of the analyte) for [14C]-radioactivity in plasma up to 336 hours Cmax (maximum measured concentration of the analyte) for BI 1482694 in plasma up to 72 hours
Trial Locations
- Locations (1)
1370.7.31001 Boehringer Ingelheim Investigational Site
🇳🇱Zuidlaren, Netherlands