Single-dose AME Study With [14C]AR882 in Healthy Male Subjects
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Mass Balance
|
Drug: [14C]AR882
Single dose of [14C]AR882
|
Outcome Measures
Primary Outcome Measures
- Total radioactivity (TRA) in urine [Days 1-14]
- TRA in feces [Days 1-14]
- TRA concentration equivalents in plasma [Days 1-14]
- TRA concentration equivalents in whole blood [Days 1-14]
- Area under the curve (AUC) for plasma [14C]-AR882 [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 [7 Days]
Profile from plasma in terms of Tmax following a single dose of [14C]-AR882
- Maximum plasma concentration (Cmax) for [14C]-AR882 [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 [7 Days]
Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882
Secondary Outcome Measures
- Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882 [Days 1-14]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
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Must have a minimum of 1 bowel movement every 2 days
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Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
Exclusion Criteria:
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Inadequate venous access or unsuitable veins for repeated venipuncture
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Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Celerion, Inc. | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Arthrosi Therapeutics
- Celerion
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AR882-103