An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Aerpio Therapeutics
- Enrollment
- 6
- Primary Endpoint
- Percent of radioactive dose recovered in urine and feces
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI 18 - 33 kg/m2
Exclusion Criteria
- •Significant cardiovascular, pulmonary, or renal disease
Arms & Interventions
AKB-9778
Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1
Intervention: AKB-9778 subcutaneous injection (Drug)
Outcomes
Primary Outcomes
Percent of radioactive dose recovered in urine and feces
Time Frame: 7 days
Cmax of AKB-9778 and any major metabolites identified
Time Frame: 7 days
Tmax of AKB-9778 and any major metabolites identified
Time Frame: 7 days
Concentration of total radioactivity in blood and plasma
Time Frame: 7 days
Elimination rate of AKB-9778 and any major metabolites identified
Time Frame: 7 days
t1/2 of AKB-9778 and any major metabolites identified
Time Frame: 7 days
AUC of AKB-9778 and any major metabolites identified
Time Frame: 7 days
Secondary Outcomes
- Incidence of adverse events and change in vital signs and laboratory values(7 days)