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

NCT05817890 | Completed Early Phase 1 FDA Drug

• 1 other identifier: CYC065-902
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Concentration of CYC065 metabolites

  Up to Day 15

• Incidence and severity of AEs

  Up to Day 15

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Fadraciclib DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, of any race, between 18 and 55 years of age, inclusive.
• Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, with a total body weight ≥50 kg.
• 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).
• Males will agree to use contraception.
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
• History of a minimum of 1 bowel movement per day.

You may not qualify if:

• 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).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• 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).
• 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.
• Positive hepatitis panel and/or positive human immunodeficiency virus test.

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (1)

Labcorp Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

CYC065

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 18, 2023
• Study Start: March 3, 2023
• Primary Completion: February 29, 2024
• Study Completion: May 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)