Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 14C-BI 409306

• Registration Number: NCT02597998
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of this study is to assess the mass balance recovery from excreta of carbon 14 labelled BI409306 (\[14C\] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-15
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Primary Completion: 2015-12-11
• Study Completion: 2015-12-11
• Status Verified: 2023-08
• Results First Submitted: 2023-08-10
• Results First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Results First Posted: 2024-03-07
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 409306 - 25 mg	14C-BI 409306	14C-BI 409306 oral solution

Primary Outcome Measures

Name	Time	Method
Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces	Urine and faeces sample collection: 17 hours before and up to 216 hours after drug administration. The details are mentioned in description section.	Mass balance recovery of total radioactivity in urine and faeces: Amount excreted within the time interval from 0 to the time of the last quantifiable data point as a percentage of the administered dose (fe0-tz) for urine and faeces. Urine collection intervals: -17:00-0:00 hours before drug administration and, 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192 and 192-216 hours after drug administration. Faeces collection intervals: -17:00-0:00, 0-24, 24-48, 48-72, 72-96, 96- 20, 120-144, 144-168, 168-192 and 192-216 hours after drug administration.

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)	PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.	Maximum measured concentration of BI 409306 in plasma (Cmax).
Area Under the Concentration-time Curve Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) for 14C-BI 409306 Related Radioactivity in Plasma	PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.	Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC0-tz) for 14C-BI 409306 related radioactivity in plasma.
Maximum Measured Concentration of 14C-BI 409306 Related Radioactivity in Plasma (Cmax)	PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.	Maximum measured concentration of 14C-BI 409306 related radioactivity in plasma (Cmax).
Area Under the Concentration-time Curve Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) for BI 409306 in Plasma	PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.	Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC0-tz) for BI 409306 in plasma.

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom