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

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ClinicalTrials.gov Identifier: NCT04508426
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: [14C]AR882 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
Actual Study Start Date : July 16, 2020
Actual Primary Completion Date : August 12, 2020
Actual Study Completion Date : August 12, 2020

Arm Intervention/treatment
Experimental: Mass Balance Drug: [14C]AR882
Single dose of [14C]AR882




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508426


Locations
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United States, Nebraska
Celerion, Inc.
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Arthrosi Therapeutics
Celerion
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Responsible Party: Arthrosi Therapeutics
ClinicalTrials.gov Identifier: NCT04508426    
Other Study ID Numbers: AR882-103
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No