Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
NCT04163783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2019-11-15
Summary
Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of \[14C\]-BGB-3111.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
[14C]-BGB-3111
20-mg capsule containing \~200 μCi of \[14C\]-BGB-3111,
- DRUG
-
BGB-3111
Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Principal Investigators
-
William Novotony, MD · BeiGene
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-03-29
- Primary Completion
- 2017-04-18
- Completion
- 2017-04-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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