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

Cyclacel Pharmaceuticals, Inc.1 site in 1 country8 target enrollmentMarch 3, 2023

ConditionsHealthy

InterventionsFadraciclib

DrugsFadraciclib

Overview

Phase: Early Phase 1
Intervention: Fadraciclib
Conditions: Healthy
Sponsor: Cyclacel Pharmaceuticals, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: t½ for CYC065 in plasma
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

March 3, 2023

End Date

February 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Cyclacel Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Exclusion Criteria
•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).

Exclusion Criteria

Not provided

Arms & Interventions

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.

Intervention: Fadraciclib