Trials / Completed
CompletedNCT05860582
A Study of [14C]GB491 in Male Healthy Subjects
A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Genor Biopharma Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [14C]GB491 | A single 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2022-11-14
- Completion
- 2022-11-14
- First posted
- 2023-05-16
- Last updated
- 2023-05-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05860582. Inclusion in this directory is not an endorsement.