Status:
COMPLETED
Single-dose AME Study With [14C]AR882 in Healthy Male Subjects
Lead Sponsor:
Arthrosi Therapeutics
Collaborating Sponsors:
Celerion
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 fe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04508426
Start Date
July 16 2020
End Date
August 12 2020
Last Update
November 16 2020
Active Locations (1)
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1
Celerion, Inc.
Lincoln, Nebraska, United States, 68502