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

CYC065-902

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

2023-03-03

2023-03-04

2024-02-01

Active (not recruiting)

Early phase I

8

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2024-02-07