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 Phase 1, open-label non-randomized, single dose study in healthy male subjects.
This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of [14C]-PBI-200
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-PBI-200 Treated | Experimental | [14C]-labeled PBI-200 will be administered as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-PBI-200 | Drug | [14C]-radio-labeled-PBI-200 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Radioactivity in Urine and Feces | 28 days | |
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)] | 28 days | |
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast) | 28 days | |
| Maximum Observed Concentration [C(max)] | 28 days | |
| Time to Maximum Concentration [T(max)] | 28 days | |
| Apparent Terminal Elimination Half-life [t(1/2)] | 28 days | |
| Total Radioactivity in Plasma and Whole Blood | 28 days | |
| Ratio for AUC(0-inf) Blood / Plasma | 28 days | |
| Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity | 28 days |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Pyramid Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc | Madison | Wisconsin | 53704 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided