Clinical trial NCT05817890: Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The routes, rates of elimination, and mass balance
timeFrame: Up to Day 15
measure: AUC for CYC065 in plasma
timeFrame: Up to Day 15
measure: Cmax for CYC065 in plasma
timeFrame: Up to Day 15
measure: Tmax for CYC065 in plasma
timeFrame: Up to Day 15
measure: t½ for CYC065 in plasma
timeFrame: Up to Day 15
Secondary outcomes:
measure: Concentration of CYC065 metabolites
timeFrame: Up to Day 15
measure: Incidence and severity of AEs
timeFrame: Up to Day 15
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit
state: Wisconsin
Study officials:
References: