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

NCT04508426 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-11-16

No results posted yet for this study

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

Interventions

DRUG

[14C]AR882

Single dose of \[14C\]AR882

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY
  • Arthrosi Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2020-08-12
Completion
2020-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508426 on ClinicalTrials.gov