Investigation of the Metabolism and Pharmacokinetics of [14C]BI 1744 CL and [14C]BI 1744 CL Administered as an Oral Solution in Healthy Male Subjects
NCT02172157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2014-06-24
Summary
Primary objective:
To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS - glucuronide and \[14C\]-radioactivity including excretion mass balance, excretion pathways and metabolism following intravenous and oral administration of \[14C\]BI 1744 CL
Secondary objective:
To determine safety and tolerability following intravenous and oral administration of \[14C\]BI 1744 CL in healthy male subjects
Conditions
- Healthy
Interventions
- DRUG
-
BI 1744 CL i.v.
- DRUG
-
BI 1744 CL oral
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2008-04-30
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