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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05817890
• Other study ID #: CYC065-902
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 3, 2023
• Est. completion date: February 2024

Study information

• Verified date: February 2024
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: February 2024
• Est. primary completion date: March 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Fadraciclib
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The routes, rates of elimination, and mass balance	Total radioactivity from [14C]-CYC065 recovery (fet1t2) in urine and feces	Up to Day 15
Primary	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
Primary	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
Primary	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
Primary	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	Concentration of CYC065 metabolites	To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after [14C]CYC065	Up to Day 15
Secondary	Incidence and severity of AEs	To assess the safety and tolerability of [14C]CYC065 when administered to healthy subjects	Up to Day 15