NL-OMON51763已完成不适用
A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]PF-07081532 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07081532 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH - Study in healthy male participants to assess the ADME of [14C]PF-07081532
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 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 64（—）
入选标准
- •1. Male participants must be 18 to 60 years of age, inclusive, at the time of
- •signing the ICF.
- •2. Male participants who are overtly healthy as determined by medical
- •evaluation including medical history, physical examination, blood pressure and
- •pulse rate measurement, standard 12-lead ECG, and laboratory tests.
- •3.BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
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).
- •Any condition possibly affecting drug absorption (eg, gastrectomy,
- •cholecystectomy).
- •Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb. Note: A
- •positive HBsAb due to hepatitis B vaccination is permissible.
- •2. Personal or family history of MTC or MEN2, or participants with suspected
- •MTC per the investigator*s judgement.
- •3. History of irregular bowel movements (eg, irritable bowel syndrome, frequent
- •episodes of diarrhea, or constipation defined by less than 1 bowel movement on
- •average per 2 days) or lactose intolerance.
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