A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- TRA concentration equivalents in plasma
Study Overview
Brief Summary
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
- •Must have a minimum of 1 bowel movement every 2 days
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
Exclusion Criteria
- •Inadequate venous access or unsuitable veins for repeated venipuncture
- •Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B
Arms & Interventions
Mass Balance
Intervention: [14C]AR882 (Drug)
Outcomes
Primary Outcomes
TRA concentration equivalents in plasma
Time Frame: Days 1-14
Total radioactivity (TRA) in urine
Time Frame: Days 1-14
TRA in feces
Time Frame: Days 1-14
TRA concentration equivalents in whole blood
Time Frame: Days 1-14
Area under the curve (AUC) for plasma [14C]-AR882
Time Frame: 7 Days
Profile from plasma in terms of AUC following a single dose of \[14C\]-AR882
Time to maximum plasma concentration (Tmax) for [14C]-AR882
Time Frame: 7 Days
Profile from plasma in terms of Tmax following a single dose of \[14C\]-AR882
Maximum plasma concentration (Cmax) for [14C]-AR882
Time Frame: 7 Days
Profile from plasma in terms of Cmax following a single dose of \[14C\]-AR882
Apparent terminal half-life (t1/2) for [14C]-AR882
Time Frame: 7 Days
Profile from plasma in terms of t1/2 following a single dose of \[14C\]-AR882
Secondary Outcomes
- Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882(Days 1-14)