NL-OMON53865已完成不适用
A Phase 1 Study to Assess the Mass Balance, Excretion, and Pharmacokinetics of [14C]-GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Healthy Participants - GBT021601 ADME Microtracer Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
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 64（—）
入选标准
- •1. Sex: Male or female.
- •2. Age: 18 to 55 years, inclusive, at screening.
- •3. Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.
- •4. Body weight: >=50 kg at screening.
- •5. Good physical and mental health on the basis of medical and surgical
- •history, physical examination, clinical laboratory (including clinical
- •chemistry, hematology, urinalysis, and coagulation), 12 lead electrocardiogram
- •(ECG), and vital signs, as judged by the Investigator.
- •Further criteria apply
排除标准
- •1. Employee of ICON or the Sponsor.
- •2. History or presence of clinically significant allergic diseases (except for
- •untreated, asymptomatic, seasonal allergies at time of dosing), in the opinion
- •of the Investigator.
- •3. History or presence of conditions which, in the opinion of the Investigator,
- •are known to interfere with the ADME of drugs, such as previous surgery on the
- •gastrointestinal tract (including removal of parts of the stomach, bowel,
- •liver, gall bladder, or pancreas). Participants who have a history of
- •appendectomy are eligible for enrollment.
- •4. History of chronic constipation, or recent complaints of an irregular
- •defecation pattern (ie, less than once per day on average) in the opinion of
- •the Investigator.
- •5. History of surgery requiring general anesthesia (not including local
- •procedures) or major trauma within 12 weeks of screening, or a planned surgery
- •during participation in the study.
- •Further criteria apply
研究者
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