A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body

Phase 1

Terminated

• Conditions: Healthy Volunteers

• Registration Number: NCT04267276
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available, safety and tolerability in healthy male subjects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Study Start: 2020-02-18
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-02
• Results First Submitted: 2021-12-17
• Results First Submitted QC: 2021-12-17
• Results First Posted: 2022-02-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 7

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

Primary Outcome Measures

Name	Time	Method
Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Urine	On Day -1 or Day 1 pre-dose (blank) sample, on Day 1 prior to start of urine collection voiding of the bladder, 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14).	Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours.; The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Faeces.	On Day -2, Day -1 or Day 1 pre-dose (blank) sample, and on Day 1 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14).	Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours.; The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.

Secondary Outcome Measures

Name	Time	Method
Part 1: Area Under the Concentration-time Curve of Total [14C]BI 1265162-equivalent (EQ) in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz))	At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).	Area under the concentration-time curve of total \[14C\]BI 1265162-EQ in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration of BI 1265162 (C-14). Plasma concentrations of (C-14) BI 1265162-radioactivity are expressed as \[14C\]BI 1265162-EQ. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Area Under the Concentration-time Curve of Total BI 1265162 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz))	At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).	Area under the concentration-time curve of total BI 1265162 in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 Metabolite M582 in Plasma	At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).	Maximum measured concentration (Cmax) of total metabolite M582 in plasma was analyzed after single dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Percentage of Participants With Drug Related Adverse Events (AEs) Including Clinically Relevant Findings From the Physical Examination	From drug administration up to 22 days.	Percentage of participants with drug related adverse events (AEs) including clinically relevant findings from the physical examination.; Percentages are calculated using total number of participants per treatment as the denominator.
Part 1: Area Under the Concentration-time Curve of Total BI 1265162 Metabolite M582 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz))	At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).	Area under the concentration-time curve of total BI 1265162 metabolite M582 in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Maximum Measured Concentration (Cmax) of Total [14C]BI 1265162-equivalent (EQ) in Plasma	At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).	Maximum measured concentration (Cmax) of total \[14C\]BI 1265162-EQ in plasma was analyzed after the single intravenous dose administration. Plasma concentrations of (C-14) BI 1265162-radioactivity are expressed as \[14C\]BI 1265162-EQ (EQ: equivalent). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 in Plasma	At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).	Maximum measured concentration (Cmax) of total BI 1265162 in plasma was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.

Trial Locations

Locations (1)

PRA Health Sciences Onderzoekscentrum Martini; 🇳🇱 Groningen, Netherlands