Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: AKB-9778 subcutaneous injection
- Registration Number
- NCT02858271
- Lead Sponsor
- Aerpio Therapeutics
- Brief Summary
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of \[14C\]-AKB-9778 in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- BMI 18 - 33 kg/m2
Exclusion Criteria
- Significant cardiovascular, pulmonary, or renal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AKB-9778 AKB-9778 subcutaneous injection Single dose of \[14C\]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1
- Primary Outcome Measures
Name Time Method Elimination rate of AKB-9778 and any major metabolites identified 7 days Cmax of AKB-9778 and any major metabolites identified 7 days Tmax of AKB-9778 and any major metabolites identified 7 days Concentration of total radioactivity in blood and plasma 7 days t1/2 of AKB-9778 and any major metabolites identified 7 days Percent of radioactive dose recovered in urine and feces 7 days AUC of AKB-9778 and any major metabolites identified 7 days
- Secondary Outcome Measures
Name Time Method Incidence of adverse events and change in vital signs and laboratory values 7 days