Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects
Completed · Early Phase 1
Conditions studied: Healthy
In brief
This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
Key facts
- Study ID
- NCT05817890
- Run by
- Cyclacel Pharmaceuticals, Inc.
- People needed
- 8
- Starts
- 2023-03-03
- Expected to finish
- 2024-05-22
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Labcorp Clinical Research Unit — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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