drugset / Trial / NCT01205373
A Phase I Trial to Investigate the Metabolism and Pharmacokinetics as Well as Safety and Tolerability of a Single Dose BI671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers.
Timeline
- Start
- 2010-09
- Primary completion
- 2010-10
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 671800 | Small molecule | 400 mg | Oral |
Indications
No indication recorded.