A Study in Healthy Men to Test How BI 456906 is Processed in the Body
- Sponsor
- Boehringer Ingelheim
- Study ID
- NCT05421338
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- BI 456906 (C-14) — DRUGBI 456906 (C-14)
Study Details
This trial is intended to examine the basic pharmacokinetics of BI 456906 and total \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity.
Key Dates
- Start date
- Jul 4, 2022
- Status verified
- Dec 2022
- Primary completion
- Nov 17, 2022
- Completion
- Nov 17, 2022
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BI 456906 (C-14)
Primary Outcome Measure
Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_urine, 0-tz) [ Time Frame: up to 7 weeks ]
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