NL-OMON51576已完成不适用
A Phase 1 Study to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C-ASTX029 in Healthy Volunteers - CS0387-220219
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male subjects and female subjects of non-childbearing potential , aged 18
- •years to 65 years, inclusive, at Screening.
- •2. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and at
- •3. Women of non-childbearing potential should be surgically sterilized or
- •physiologically incapable of becoming pregnant or should be postmenopausal.
- •Surgically sterile women are defined as those who have had a hysterectomy,
- •bilateral ovariectomy, or bilateral tubal ligation. Women who are surgically
- •sterile must provide documentation of the procedure. Postmenopausal women must
- •have had >=12 months of spontaneous amenorrhea (with documented
- •follicle-stimulating hormone (FSH) >=33.4 mIU/mL). All women must have a
- •negative pregnancy test result at Screening and on Day -1 of Period 1.
- •4. Male subjects, if not surgically sterilized, must agree to use adequate
- •contraception and not donate sperm from first admission to the clinical
- •research center until 90 days after the follow-up visit. Adequate contraception
- •for male subjects who are sexually active with women of childbearing potential
- •(WOCBP) entails the use of a latex or other synthetic condom during any sexual
- •activity with WOCBP until 90 days after the follow-up visit. Total abstinence,
- •in accordance with the lifestyle of the subject, is also acceptable.
- •5. Satisfactory physical and mental health at Screening and on Day -1 on the
- •basis of medical history, physical examination, clinical laboratory, 12-lead
- •electrocardiogram (ECG) in triplicate, and vital signs, as judged by the
- •Principal Investigator.
排除标准
- •1. Employee of clinical research organization (CRO) or the Sponsor.
- •2. Clinically significant systemic allergic disease or a history of significant
- •drug and/or food allergies, including, but not limited to, a history of
- •anaphylactic reactions, or allergic reactions due to any drug and/or food
- •leading to significant morbidity.
- •3. Use of any prescription drugs within 30 days or 5 half-lives (whichever is
- •longer) prior to each admission to the clinic.
- •4. Use of any non-prescription drugs (excluding paracetamol), vitamin
- •preparations and other food supplements, or herbal medications (eg, St John*s
- •Wort) within 14 days prior to each admission to the clinic.
研究者
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