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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]AR882

• Registration Number: NCT04508426
• Lead Sponsor: Arthrosi Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Status Verified: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mass Balance	[14C]AR882	-

Primary Outcome Measures

Name	Time	Method
TRA concentration equivalents in plasma	Days 1-14
Total radioactivity (TRA) in urine	Days 1-14
TRA in feces	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

Name	Time	Method
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882	Days 1-14

Trial Locations

Locations (1)

Celerion, Inc.; 🇺🇸 Lincoln, Nebraska, United States