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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Fadraciclib

Detailed 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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Males, of any race, between 18 and 55 years of age, inclusive.
2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, with a total body weight ≥50 kg.
3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
4. Males will agree to use contraception.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
6. History of a minimum of 1 bowel movement per day.

Exclusion Criteria

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
4. Confirmed (eg, 2 consecutive measurements) systolic blood pressure >140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg or <50 mmHg, and pulse rate >100 beats per minute or <40 beats per minute.
5. Positive hepatitis panel and/or positive human immunodeficiency virus test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Up to 8 subjects will be enrolled and studied as a single group; 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; Other Names: CYC065

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The routes, rates of elimination, and mass balance	Total radioactivity from [14C]-CYC065 recovery (fet1t2) in urine and feces	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	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	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	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	Up to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of CYC065 metabolites	To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after [14C]CYC065	Up to Day 15
Incidence and severity of AEs	To assess the safety and tolerability of [14C]CYC065 when administered to healthy subjects	Up to Day 15

Collaborators and Investigators

• Sponsor: Cyclacel Pharmaceuticals, Inc.
• Investigators: Study Chair: Mark H Kirschbaum, MD, Cyclacel Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CYC065-902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No