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
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
More Related Trials
-
Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX
NCT01367483 ·Status: COMPLETED ·Phase: PHASE1
-
Radiolabeled Study of AG-221 in Healthy Male Subjects.
NCT02443168 ·Status: COMPLETED ·Phase: PHASE1
-
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
NCT01048203 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
NCT01058447 ·Status: COMPLETED ·Phase: PHASE1
-
A Single-center Study to Investigate How Quickly and to What Extent a Radioactive Dose of RO5285119 is Absorbed, Metabolized and Eliminated From the Body of Healthy Male Volunteers
NCT02179866 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
NCT04415645 ·Status: COMPLETED ·Phase: PHASE1
-
Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions
NCT03608319 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants
NCT05284890 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects
NCT01818232 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
NCT04655898 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers
NCT01605461 ·Status: COMPLETED ·Phase: PHASE1
-
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
NCT01684891 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
NCT05074134 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human
NCT05836805 ·Status: UNKNOWN ·Phase: PHASE1
-
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
NCT01786876 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
NCT05578859 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
NCT01592890 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body
NCT03654170 ·Status: COMPLETED ·Phase: PHASE1
-
This Study in Healthy Men Tests How the Body Takes up BI 1467335
NCT03483506 ·Status: COMPLETED ·Phase: PHASE1
-
AME Study of [14C]-YH4808 in Healthy Male Subjects
NCT01825707 ·Status: COMPLETED ·Phase: PHASE1
-
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
NCT01448395 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
NCT02126514 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
NCT00829088 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)
NCT02835976 ·Status: COMPLETED ·Phase: PHASE1
-
This Study Tests BI 1467335 in Healthy Male Volunteers. The Study Tests How Different Doses of BI 1467335 Are Taken up and Handled by the Body
NCT03382509 ·Status: COMPLETED ·Phase: PHASE1