NCT04495140已完成1 期
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961
适应症
干预措施
相关药物
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 recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1
研究概览
简要总结
This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants between 18 to 54 years of age
- •Healthy and capable of signing informed consent document
- •Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures
- •Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).
排除标准
- •acute or chronic medical or psychiatric condition including recent (within the past year)
- •Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements
- •Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days prior to the first dose of investigational product.
- •Previous administration with an investigational drug within 60 days (or as determined by the local requirement) preceding the first dose of investigational product used in this study.
- •Known prior participation in a trial involving PF-06882961 or known intolerance to a GLP-1R agonist.
- •A positive urine drug test on screening or Day -
- •Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- •Participants with abnormalities in clinical laboratory tests including ECGs, vital signs, liver function tests, myocardial infarction
- •Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- •History of alcohol or tobacco abuse or binge drinking and/or any other illicit drug use or dependence within past 6 months.
- •Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin is planned to flush intravenous catheters.
- •Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
研究组 & 干预措施
Oral [14C]PF-06882961, 50 mg
Experimental
In this arm, a single oral dose of [14C]PF-06882961, 50 mg will be administered as a liquid formulation.
干预措施: [14C]PF-06882961, 50 mg (Drug)
Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug
Experimental
In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961, 100 ug, will be administered via intravenous infusion.
干预措施: PF-06882961, 50 mg and [14C]PF-06882961, 100 ug (Drug)
结局指标
主要结局
Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1
时间窗: Baseline through approximately hour 312 (day 14). Period 1 is 14 days
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
次要结局
- Metabolite profiling/identification in plasma, urine, and feces(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr))
- Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961(0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr)
- Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961(0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr)
- Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961(00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Number of participants with ECG measurements above/below certain threshold(baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days))
- Number of participants with vital measurements above/below certain threshold(baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days))
- Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961(0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr)
- Absolute oral bioavailability (F)(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Fraction of dose absorbed following single oral administration of [14C]PF-06882961(0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr)
- Number of participants with adverse events(Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days)
- Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961(00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr)
- Number of participants with safety laboratory test results above/below certain threshold(baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days))
研究者
研究点 (2)
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