Trials / Completed
CompletedNCT03664011
A Study in Healthy Men to Test How BI 730357 is Processed by the Body
A Phase I, Open-label, Single-dose Trial to Investigate Metabolism and Pharmacokinetics of BI 730357 BS (C-14) Administered as Oral Solution in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The main objectives of the study are as follows: * To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as 14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base (BS) (C-14) in healthy male subjects * To provide plasma, urine, and faecal samples for metabolite profiling and structural identification
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 730357 mixed with [C-14]BI 730357 BS | Oral Solution |
Timeline
- Start date
- 2018-09-10
- Primary completion
- 2018-11-13
- Completion
- 2018-11-13
- First posted
- 2018-09-10
- Last updated
- 2023-07-12
- Results posted
- 2023-07-12
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03664011. Inclusion in this directory is not an endorsement.