NL-OMON50100已完成不适用
A phase 1, open label, 2-period, fixed sequence, study to assess the mass balance, absolute bioavailability of 14C-PF-06826647 in healthy male participants - Mass balance and absolute bioavailability of 14C-PF-06826647 in men.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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. Healthy male participants must be 18 to 55 years of age, inclusive, at the
- •time of signing the ICD.
- •2. Male participants who are overtly healthy as determined by medical
- •evaluation including medical history, physical examination, including BP and
- •pulse rate measurement, laboratory tests, and 12-lead ECG.
- •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 30.0 kg/m2; and a total body weight >50 kg (110 lb).
- •5. Capable of giving signed informed consent as described in Appendix 1 of the
- •protocol, which includes compliance with the requirements and restrictions
- •listed in the ICD and in this protocol.
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).
- •3. History of irregular bowel movements including irritable bowel syndrome or
- •frequent 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.
- •-For hepatitis B, all participants will undergo testing for HBsAg and HBcAb
- •during screening. Participants who are HBsAg positive will not be eligible for
- •this study. Participants who are HBsAg negative but HBcAb positive will be
- •reflex tested for HBsAb. The participant will be eligible if HBsAb is positive.
- •-For hepatitis C, all participants will undergo testing for HCVAb during
- •screening.Participants who are HCVAb positive will be reflex tested for
- •hepatitis C ribonucleic acid (HCV RNA). Participants who are HCVAb and HCV RNA
- •positive are not eligible for the study. Participants who are HCVAb positive
- •but HCV RNA negative will be considered eligible.
- •5. Other medical or psychiatric condition including recent (within the past
- •year) or 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.
- •11. A positive COVID-19 test or suspected of having SARS-CoV2 infection.
- •Further criteria apply, referring to protocol.
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