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Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects

Healthy Clinical Trial

Official title:
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects

Clinical Trial Summary

This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.

Clinical Trial Description

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 (168 hours post dose). On Day 1, subjects will receive a single oral dose of [14C]-CYC065. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥90% mass balance recovery, and ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site until all discharge criteria are met up to a maximum of Day 15. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05817890
Study type Interventional
Source Cyclacel Pharmaceuticals, Inc.
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date March 3, 2023
Completion date February 2024
View Details
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