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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508426
• Other study ID #: AR882-103
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2020
• Est. completion date: August 12, 2020

Study information

• Verified date: August 2020
• Source: Arthrosi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Celerion, Inc.	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Arthrosi Therapeutics	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity (TRA) in urine		Days 1-14
Primary	TRA in feces		Days 1-14
Primary	TRA concentration equivalents in plasma		Days 1-14
Primary	TRA concentration equivalents in whole blood		Days 1-14
Primary	Area under the curve (AUC) for plasma [14C]-AR882	Profile from plasma in terms of AUC following a single dose of [14C]-AR882	7 Days
Primary	Time to maximum plasma concentration (Tmax) for [14C]-AR882	Profile from plasma in terms of Tmax following a single dose of [14C]-AR882	7 Days
Primary	Maximum plasma concentration (Cmax) for [14C]-AR882	Profile from plasma in terms of Cmax following a single dose of [14C]-AR882	7 Days
Primary	Apparent terminal half-life (t1/2) for [14C]-AR882	Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882	7 Days
Secondary	Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882		Days 1-14