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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fadraciclib


Participation Criteria
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Eligibility Criteria
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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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Up to 8 subjects will be enrolled and studied as a single group<br>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<br>* Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects<br>* Other names: CYC065;|

What is the study measuring?
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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 |