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Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKB-9778 | Experimental | Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-9778 subcutaneous injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of radioactive dose recovered in urine and feces | 7 days | |
| Concentration of total radioactivity in blood and plasma | 7 days | |
| Cmax of AKB-9778 and any major metabolites identified | 7 days | |
| Tmax of AKB-9778 and any major metabolites identified | 7 days | |
| AUC of AKB-9778 and any major metabolites identified | 7 days | |
| t1/2 of AKB-9778 and any major metabolites identified | 7 days | |
| Elimination rate of AKB-9778 and any major metabolites identified | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and change in vital signs and laboratory values | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akshay Buch, PhD | Aerpio Therapeutics | Study Chair |
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