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

Sponsor
Arthrosi Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT04508426
Collaborator
Celerion (Industry)
6
1
1
27
6.8

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jul 16, 2020
Actual Primary Completion Date :
Aug 12, 2020
Actual Study Completion Date :
Aug 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mass Balance

Drug: [14C]AR882
Single dose of [14C]AR882

Outcome Measures

Primary Outcome Measures

  1. Total radioactivity (TRA) in urine [Days 1-14]

  2. TRA in feces [Days 1-14]

  3. TRA concentration equivalents in plasma [Days 1-14]

  4. TRA concentration equivalents in whole blood [Days 1-14]

  5. Area under the curve (AUC) for plasma [14C]-AR882 [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 [7 Days]

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

  7. Maximum plasma concentration (Cmax) for [14C]-AR882 [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 [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 [Days 1-14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion, Inc. Lincoln Nebraska United States 68502

Sponsors and Collaborators

  • Arthrosi Therapeutics
  • Celerion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arthrosi Therapeutics
ClinicalTrials.gov Identifier:
NCT04508426
Other Study ID Numbers:
  • AR882-103
First Posted:
Aug 11, 2020
Last Update Posted:
Nov 16, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 16, 2020