ISRCTN10152571已完成1 期
A Phase I, open-label study of the absorption, metabolism, and excretion of [14C]-GDC-6036 following a single oral dose in healthy male subjects
F. Hoffmann-La Roche (Switzerland)0 个研究点目标入组 8 人开始时间: 2023年3月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Male participants, between 18 and 65 years of age, inclusive
- •2. Within body mass index (BMI) range 18.0 to 32.0 kilograms per meter square (kg/m²), inclusive
- •3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
- •4. Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], complete blood count [CBC], and urinalysis [UA] with complete microscopic examination) within the reference range for the test laboratory, unless deemed not clinically significant by the investigator
- •5. Negative test for selected drugs of abuse at Screening
- •6. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
- •7. Participants who have a history of a minimum of 1 bowel movement per day
排除标准
- •1. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •2. Administration of a COVID-19 vaccine in the past 30 days prior to Screening
- •3. History of malignancy, except for a history of 5 years or more of appropriately treated non-melanoma skin carcinoma
- •4. Exposure to significant diagnostic or therapeutic radiation (e.g., 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 (Day -1)
- •5. Participation in more than three radiolabelled drug studies in the last 12 months (previous study to be at least 4 months prior to Check-in [Day -1] where exposures are known to the investigator or 6 months prior to Check-in [Day -1] for a radiolabelled drug study where exposures are not known to the investigator). The total 12-month exposure from this study and a maximum of two other previous radiolabelled studies within 4 to 12 months prior to this study will be within the CFR-recommended levels considered safe, per US Title 21CFR 361.1
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