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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose
研究概览
简要总结
The purpose of the study is to determine the metabolism and excretion following a single oral administration of 14C-PF-06826647-LR (14C labelled PF-06826647 with lower radioactivity per mass unit) in fed conditions. This information will enable assessment of clearance mechanisms of PF-06826647 as well as identify metabolites. In addition, this study will determine absolute bioavailability of PF-06826647 and understand intravenous (IV) pharmacokinetic (PK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male participants must be 18 to 55 years of age, inclusive.
- •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.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •BMI of 17.5 to 30 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •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).
- •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.
- •Participants who currently use or have formerly used (within 6 months of dosing) tobacco or nicotine containing products.
- •Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
研究组 & 干预措施
PF-06826647 600 mg PO>PF-06826647 600 mg PO+100 ug IV
PF-06826647 600 mg single dose in Period 1 followed by PF-06826647 600 mg PO and IV infusion of 100 ug of PF-06826647 in Period 2.
干预措施: 14C-PF-06826647-LR 600 mg PO (Drug)
PF-06826647 600 mg PO>PF-06826647 600 mg PO+100 ug IV
PF-06826647 600 mg single dose in Period 1 followed by PF-06826647 600 mg PO and IV infusion of 100 ug of PF-06826647 in Period 2.
干预措施: PF-06826647 600 mg PO (Drug)
PF-06826647 600 mg PO>PF-06826647 600 mg PO+100 ug IV
PF-06826647 600 mg single dose in Period 1 followed by PF-06826647 600 mg PO and IV infusion of 100 ug of PF-06826647 in Period 2.
干预措施: 14C-PF-06826647 100 ug IV (Drug)
结局指标
主要结局
Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose
时间窗: Up to Day 14
次要结局
- Number of participants with abnormal ECG(Up to Day 28)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Up to Day 28)
- Number of Participants With Laboratory Test Values of Potential Clinical Importance(Up to Day 28)
- The ratio of dose normalized AUCinf of PF-06826647 and 14C-PF-06826647(0 hours to 96 hours)