A Study in Healthy Men to Test How BI 1569912 is Processed in the Body

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1569912 (C-14); Drug: BI 1569912 (C-13)

• Registration Number: NCT06520553
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are:

* To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).

* To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-08-26
• Primary Completion: 2024-10-03
• Study Completion: 2024-10-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14

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
BI 1569912 (C-14) followed by BI 1569912 (C-13)	BI 1569912 (C-14)	BI 1569912 (C-14) = \[test treatment, T\] BI 1569912 (C-13) = \[reference treatment, R\]
BI 1569912 (C-14) followed by BI 1569912 (C-13)	BI 1569912 (C-13)	BI 1569912 (C-14) = \[test treatment, T\] BI 1569912 (C-13) = \[reference treatment, R\]

Primary Outcome Measures

Name	Time	Method
AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)	up to Day 13.
Mass balance recovery for [ 14 C]- radioactivity in urine after oral administration of BI 1569912 (C-14): 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 Day 14.
Mass balance recovery for [ 14 C]- radioactivity in faeces after administration of BI 1569912 (C-14): 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 Day 14.
AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of [ 13 C] BI 1569912 after a single intravenous infusion of BI 1569912 (C-13)	up to Day 6.
Mass balance recovery for [14C]- radioactivity in urine and faeces after oral administration of BI 1569912 (C-14): Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)	up to Day 14.

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)	up to Day 13.
Cmax (maximum measured concentration in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14)	up to Day 13.
AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14)	up to Day 13.
AUC0-tz of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C-13)	up to Day 6.
AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)	up to Day 13.
Cmax of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C- 13)	up to Day 6.

Trial Locations

Locations (1)

ICON-Groningen-62040; 🇳🇱 Groningen, Netherlands