A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat

This is an interventional treatment trial for Cutaneous T Cell Lymphoma Read More

Inclusion Criteria:

• Male
• Age between 35 (inclusive) and 55 years of age (inclusive)
• Body mass index between 18.0 and 28.0 kg/m2, inclusive but at least 60 kg of body weight.
• Healthy, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert Meulengracht's syndrome based on total and direct bilirubin] is not acceptable) at screening and/or check-in as assessed by the investigator (or designee).
• Subjects must 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.
• Subjects must agree not to donate sperm from check-in until 90 days after discharge.

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).
• Any of the following abnormalities in laboratory test values and/or ECG at screening and/or check-in, confirmed by repeat: hemoglobin, white blood cell count, total platelets, and QTcF outside of normal range; alanine aminotransferase, aspartate aminotransferase, and creatinine values > upper limit of normal; and estimated glomerular filtration rate (calculated using Cockcroft-Gault formula) <60 mL/min.
• 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 >150 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >90 or <40 beats per minute.
• History of alcoholism or drug/chemical abuse within 2 years prior to screening.
• Alcohol consumption of > 21 units per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
• Positive hepatitis panel and/or positive human immunodeficiency virus test
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives, whichever is longer prior to dosing.
• Administration of any vaccination (including vaccines currently being deployed in the UK for SARS-CoV-27) within the past 90 days prior to dosing.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, and excretion processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine test at screening or check-in.
• Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
• Receipt of blood products within 2 months prior to check-in.
• Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
• Poor peripheral venous access
• Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
• Subjects who have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
• Subjects who, in the opinion of the investigator (or designee), should not participate in this study.