NCT03770039已完成1 期
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH
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
- mass balance_urine
研究概览
简要总结
An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
- •Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
- •History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
- •Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
- •Use of herbal supplements within 28 days prior to the first dose of study medication
- •Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by Pfizer
- •Inability to have at least one bowel movement every 2 days on average eGFR of <90 mL/mim/1.73 m2 based on MDRD equation
- •Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.
研究组 & 干预措施
2-period, fixed sequence
Experimental
fixed sequence with 2 treatment period
干预措施: Oral PF-06700841 containing 14C microtracer (Drug)
2-period, fixed sequence
Experimental
fixed sequence with 2 treatment period
干预措施: Oral unlabeled PF-06700841 (Drug)
2-period, fixed sequence
Experimental
fixed sequence with 2 treatment period
干预措施: IV 14C-labeled PF-06700841 (Drug)
结局指标
主要结局
mass balance_urine
时间窗: hour 0 up to 312 hours post dose
cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
mass balance_feces
时间窗: hour 0 up to 312 hours post dose
cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
次要结局
- plasma Tmax for total 14C radioactivity(hour 0 up to 312 hours post dose)
- plasma AUCinf for total 14C radioactivity(hour 0 up to 312 hours post dose)
- plasma Cmax for PF-06700841(hour 0 up to 96 hours post dose)
- plasma Tmax for PF-06700841(hour 0 up to 96 hours post dose)
- Oral clearance for total 14C radioactivity(hour 0 up to 312 hours post dose)
- plasma half-life for total 14C radioactivity(hour 0 up to 312 hours post dose)
- plasma AUClast for PF-06700841(hour 0 up to 96 hours post dose)
- Oral clearance for PF-06700841(hour 0 up to 96 hours post dose)
- plasma half-life for PF-06700841(hour 0 up to 96 hours post dose)
- plasma Cmax for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- plasma AUCinf for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- plasma half-life for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- renal clearance of PF-06700841(hour 0 up to 96 hours post dose)
- metabolite identification_plasma(hour 0 up to 312 hours post dose)
- plasma Cmax for total 14C radioactivity(hour 0 up to 312 hours post dose)
- plasma AUClast for total 14C radioactivity(hour 0 up to 312 hours post dose)
- volume of distribution for total 14C radioactivity(hour 0 up to 312 hours post dose)
- plasma AUCinf for PF-06700841(hour 0 up to 96 hours post dose)
- volume of distribution for PF-06700841(hour 0 up to 96 hours post dose)
- plasma Tmax for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- plasma AUClast for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- clearance for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- Bioavailability of oral PF-06700841(hour 0 up to 96 hours post dose)
- metabolite identification_urine(hour 0 up to 312 hours post dose)
- metabolite identification_feces(hour 0 up to 312 hours post dose)
- volume of distribution for 14C-labeled PF-06700841(hour 0 up to 96 hours post dose)
- unchanged PF-06700841 recovered in urine(hour 0 up to 96 hours post dose)
- Fraction absorbed of oral PF-06700841(hour 0 up to 144 hours post dose)
研究者
研究点 (2)
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