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

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-29
• Study Start: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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