NL-OMON49734撤回不适用
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06835919 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06835919 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH. - A Phase 1 ADME Study of 14C-PF-06835919 in Healthy Male Participants.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer Inc.
- 入组人数
- 6
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 participants must be nonsmoking, 18 to <55 years of age, inclusive
- •2. Male participants who are overtly healthy as determined by medical
- •evaluation including medical history, physical examination, laboratory tests,
- •and cardiac tests.
- •3. Participants who are willing and able to comply with all scheduled visits,
- •treatment plan, laboratory tests, lifestyle considerations, and other study
- •procedures.
- •4. BMI of 17.5 to 30 kg/m2; and a total body weight >50 kg (110 lb).
- •5. Capable of giving signed informed consent
排除标准
- •1. Evidence or history of clinically significant hematological, renal,
- •endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
- •neurological, or allergic disease (including drug allergies, but excluding
- •untreated, asymptomatic, seasonal allergies at the time of dosing).
- •2. Any condition possibly affecting drug absorption (eg, gastrectomy,
- •cholecystectomy,
- •appendectomy).
- •3. History of irregular bowel movements including irritable bowel syndrome or
- •episodes of diarrhea or constipation defined by less than 1 bowel movement on
- •average per 2 days or lactose intolerance.
- •4. History of HIV infection, hepatitis B, or hepatitis C; positive testing for
- •HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- •5. Other medical or psychiatric condition including recent (within the past
- •active suicidal ideation/behavior or laboratory abnormality that may increase
- •the risk of study participation or, in the investigator*s judgment, make the
- •participant inappropriate for the study.
- •Further criteria apply, referring to protocol.
研究者
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