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

Arthrosi Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C]AR882

Study type: Interventional

Funder types: Industry

Identifiers

NCT04508426

AR882-103

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Mass Balance

Experimental group

Treatment:

Drug: [14C]AR882