Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.
This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6 healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately 150 µCi of [14C]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]DBPR108 | Experimental | Subjects will receive a single oral 100 mg (radioactivity of 150 µCi) dose of [14C]DBPR108 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]DBPR108 | Drug | [14C]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity in urine and feces | From time zero up to 240 hours post-dose following oral administration of [14] DBPR108 | |
| Peak plasma concentration (Cmax) | From time zero up to 96 hours post-dose following oral administration of [14] DBPR108 | |
| Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUClast) | From time zero up to 96 hours post-dose following oral administration of [14] DBPR108 | |
| Area under the plasma concentration versus time curve from time zero to infinity (AUCinf) | From time zero up to 96 hours post-dose following oral administration of [14] DBPR108 | |
| Time to achieve maximum plasma concentration (Tmax) | From time zero up to 96 hours post-dose following oral administration of [14] DBPR108 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0 | From time zero up to 240 hours post-dose following oral administration of [14] DBPR108 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Soochow University | Suzhou | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided