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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1335-9200 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) | |
| 2026-525825-19 | Registry Identifier | CTIS (EU) |
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The main objectives of this trial are:
To assess the mass balance (total recovery of [14C]-radioactivity) in urine, faeces, and expired air after a single subcutaneous dose of BI 3034701 (C-14) in healthy male trial participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3034701 (C-14) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3034701 (C-14) | Drug | BI 3034701 mixed with [C-14]BI 3034701 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 (feurine, 0-tz) | Up to Day 50. | |
| Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces, 0-tz) | Up to Day 50. | |
| Fraction of [14C]-radioactivity excreted in expired air expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feexpired air, 0-tz) | Up to Day 49. | |
| Sum of feurine, 0-tz, fefaeces, 0-tz and feexpired air, 0-tz | Up to Day 50. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of [14C]-radioactivity in plasma | Up to Day 22. | |
| Maximum measured concentration of BI 3034701 in plasma | Up to Day 22. | |
| Area under the concentration-time curve of [14C]-radioactivity in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
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| Up to Day 22. |
| Area under the concentration-time curve of BI3034701 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) | Up to Day 22. |