Trials / Terminated
TerminatedNCT04267276
A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Intravenous Administration (Part 1) and Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Oral Administration (Part 2) in Healthy Male Subjects Following a Non-randomized, Open-label, Single-dose, Single Arm Per Trial Part Mass Balance Design
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Part 1: BI 1265162 - intravenous | Intravenous solution |
| DRUG | Part 2: BI 1265162 - oral | Oral solution |
Timeline
- Start date
- 2020-02-18
- Primary completion
- 2020-04-02
- Completion
- 2020-04-02
- First posted
- 2020-02-12
- Last updated
- 2022-06-01
- Results posted
- 2022-02-23
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04267276. Inclusion in this directory is not an endorsement.