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

NCT ID: NCT04508426

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-16

Study Completion Date

2020-08-12

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mass Balance

Group Type EXPERIMENTAL

[14C]AR882

Intervention Type DRUG

Single dose of \[14C\]AR882

Interventions

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[14C]AR882

Single dose of \[14C\]AR882

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Celerion

INDUSTRY

Sponsor Role collaborator

Arthrosi Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion, Inc.

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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AR882-103

Identifier Type: -

Identifier Source: org_study_id