An Early Phase 1 interventional study of Fadraciclib in Healthy, sponsored by Cyclacel Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Cyclacel Pharmaceuticals, Inc. · Early Phase 1, Interventional, and Treatment
This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
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.
Cyclacel Pharmaceuticals, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of \[14C\]CYC065 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male subjects following a single oral administration.
Drug: Fadraciclib
Open-label Study of the Absorption, Metabolism, and Excretion of \[14C\]-CYC065 Following a Single Oral Dose in Healthy Male Subjects
Also known as: CYC065
The routes, rates of elimination, and mass balance
Total radioactivity from \[14C\]-CYC065 recovery (fet1t2) in urine and feces
Time frame: Up to Day 15
AUC for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
Cmax for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
Tmax for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
t½ for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
Concentration of CYC065 metabolites
To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after \[14C\]CYC065
Time frame: Up to Day 15
Incidence and severity of AEs
To assess the safety and tolerability of \[14C\]CYC065 when administered to healthy subjects
Time frame: Up to Day 15
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Cyclacel Pharmaceuticals, Inc.