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Cyclin-Dependent Kinase Inhibitor

Up to 8 subjects will be enrolled and studied as a single group for Healthy Subjects

Phase < 1
Waitlist Available
Research Sponsored by Cyclacel Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 15
Awards & highlights

Study Summary

This trial will study how a drug is absorbed, broken down, and excreted in healthy men.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC for CYC065 in plasma
Cmax for CYC065 in plasma
The routes, rates of elimination, and mass balance
+2 more
Secondary outcome measures
Concentration of CYC065 metabolites
Incidence and severity of AEs

Trial Design

1Treatment groups
Experimental Treatment
Group I: Up to 8 subjects will be enrolled and studied as a single groupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Cyclacel Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
2,471 Total Patients Enrolled
Mark H Kirschbaum, MDStudy ChairCyclacel Pharmaceuticals, Inc.
1 Previous Clinical Trials
330 Total Patients Enrolled

Media Library

Fadraciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05817890 — Phase < 1
Healthy Subjects Research Study Groups: Up to 8 subjects will be enrolled and studied as a single group
Healthy Subjects Clinical Trial 2023: Fadraciclib Highlights & Side Effects. Trial Name: NCT05817890 — Phase < 1
Fadraciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05817890 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor restricted to persons aged 20 or above?

"According to the inclusion criteria, those wishing to participate in this study must be between 18 and 55 years old. There are additional trials for individuals under 18 (56 studies) as well as a larger number of research opportunities available for people over 65 (367 studies)."

Answered by AI

To what criteria do patients have to adhere in order to participate in this research?

"This clinical trial is currently seeking 8 healthy participants aged between 18 and 55. Furthermore, male candidates must commit to contraception use, while all applicants must have at least one bowel movement per day in their medical history."

Answered by AI

Is this venture currently open to new participants?

"Per the information found on clinicaltrials.gov, no new participants are being recruited for this medical trial at present. The study was initially posted in March of 2023 and has not been updated since April 5th of that same year. Despite this particular trial's lack of recruitment opportunities, 812 other trials remain open to applicants presently."

Answered by AI
~4 spots leftby Apr 2025