Copanlisib Mass Balance Study
NCT02119221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2014-10-28
Summary
The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Copanlisib (BAY80-6946)
Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of \[14C\]
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2014-04-30
- Completion
- 2014-10-31
Countries
- Netherlands
Study Locations
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