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Completed

NCT Number: NCT04508426

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]AR882

Drug

Single dose of [14C]AR882

Primary outcomes

  1. Total radioactivity (TRA) in urine

    Time frame: Days 1-14

  2. TRA in feces

    Time frame: Days 1-14

  3. TRA concentration equivalents in plasma

    Time frame: Days 1-14

  4. TRA concentration equivalents in whole blood

    Time frame: Days 1-14

  5. Area under the curve (AUC) for plasma [14C]-AR882

    Time frame: 7 Days

    Profile from plasma in terms of AUC following a single dose of [14C]-AR882

  6. Time to maximum plasma concentration (Tmax) for [14C]-AR882

    Time frame: 7 Days

    Profile from plasma in terms of Tmax following a single dose of [14C]-AR882

  7. Maximum plasma concentration (Cmax) for [14C]-AR882

    Time frame: 7 Days

    Profile from plasma in terms of Cmax following a single dose of [14C]-AR882

  8. Apparent terminal half-life (t1/2) for [14C]-AR882

    Time frame: 7 Days

    Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882

Secondary outcomes

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

    Time frame: Days 1-14

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Collaborators

  • Celerion

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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