A Study of [14C]GB491 in Male Healthy Subjects
NCT05860582 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-05-16
Summary
This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.
In addition, this study will also evaluate the safety of a single dose of \[14C\]GB491 when given to healthy subjects.
Conditions
- Breast Cancer
- Nonsmall Cell Lung Cancer
Interventions
- DRUG
-
[14C]GB491
A single 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491.
Sponsors & Collaborators
-
Genor Biopharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Fang HOU, Master · Beijing GoBroad Boren Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-14
- Primary Completion
- 2022-11-14
- Completion
- 2022-11-14
Countries
- China
Study Locations
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