NCT03641573

Phase 1 Study to Evaluate ASN002 Absorption, Metabolism, and Excretion of [14C] Following a Single Oral Dose in Healthy Male Subjects

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] ASN002 Following a Single Oral Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of \[14C\] ASN002 Following a Single Oral Dose in Healthy Male Subjects

Detailed description

This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be confined to the CRU until at least Day 7. On Day 1, subjects will receive a single oral dose of \[14C\] ASN002 at 60 mg containing approximately 300 μCi \[14C\] ASN002. Subjects will be discharged on Day 7 if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, and ≥90% mass balance recovery, or ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24 hour periods. If discharge criteria are not met by Day 7, subjects will remain in the CRU up to a maximum of Day 10.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	[14C] ASN002	\[14C\] ASN002

Timeline

• Start date: 2018-10-11
• Primary completion: 2018-10-21
• Completion: 2018-10-21
• First posted: 2018-08-22
• Last updated: 2020-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study