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

A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]AR882

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mass Balance	Drug: [14C]AR882; Single dose of [14C]AR882

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Profile from plasma in terms of AUC following a single dose of [14C]-AR882	7 Days
Time to maximum plasma concentration (Tmax) for [14C]-AR882	Profile from plasma in terms of Tmax following a single dose of [14C]-AR882	7 Days
Maximum plasma concentration (Cmax) for [14C]-AR882	Profile from plasma in terms of Cmax following a single dose of [14C]-AR882	7 Days
Apparent terminal half-life (t1/2) for [14C]-AR882	Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882	7 Days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arthrosi Therapeutics
• Collaborators: Celerion

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Actual): August 12, 2020
• Study Completion (Actual): August 12, 2020

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AR882-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No