Single-dose AME Study With [14C]AR882 in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04508426

Run by

Arthrosi Therapeutics

People needed

6

Starts

2020-07-16

Expected to finish

2020-08-12

Last updated by the study team

2020-11-16

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion, Inc. — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.