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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 6, 2020
First Posted Date  ICMJE August 11, 2020
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE July 16, 2020
Actual Primary Completion Date August 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Total radioactivity (TRA) in urine [ Time Frame: Days 1-14 ]
  • TRA in feces [ Time Frame: Days 1-14 ]
  • TRA concentration equivalents in plasma [ Time Frame: Days 1-14 ]
  • TRA concentration equivalents in whole blood [ Time Frame: Days 1-14 ]
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882 [ Time Frame: Days 1-14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-dose AME Study With [14C]AR882 in Healthy Male Subjects
Official Title  ICMJE A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: [14C]AR882
Single dose of [14C]AR882
Study Arms  ICMJE Experimental: Mass Balance
Intervention: Drug: [14C]AR882
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2020)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 12, 2020
Actual Primary Completion Date August 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04508426
Other Study ID Numbers  ICMJE AR882-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Arthrosi Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arthrosi Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Celerion
Investigators  ICMJE Not Provided
PRS Account Arthrosi Therapeutics
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP