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

A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04508426

Enrollment

Registered

2020-08-11

Start date

2020-07-16

Completion date

2020-08-12

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUG[14C]AR882

Single dose of \[14C\]AR882

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
Total radioactivity (TRA) in urine	Days 1-14	—
TRA in feces	Days 1-14	—
TRA concentration equivalents in plasma	Days 1-14	—
TRA concentration equivalents in whole blood	Days 1-14	—
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
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
Maximum plasma concentration (Cmax) for [14C]-AR882	7 Days	Profile from plasma in terms of Cmax following a single dose of \[14C\]-AR882

Secondary

Measure	Time frame
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882	Days 1-14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026