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

NCT04508426 | Completed Phase 1 FDA Drug

• 1 other identifier: AR882-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882

  Days 1-14

Study Arms (1)

Mass Balance

EXPERIMENTAL

Drug: [14C]AR882

Interventions

[14C]AR882 DRUG

Single dose of \[14C\]AR882

Mass Balance

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Arthrosi Therapeutics: lead
• Celerion: collaborator

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: July 16, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)