NCT02936154已完成1 期
A Phase 1, Double Blind (Sponsor Open), Placebo-controlled, Multiple-dose Study To Evaluate The Tolerability, Safety And Pharmacokinetics Of A Modified Release Formulation Of Pf-06650833 Under Fed Condition In Healthy Adult Japanese Subjects
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
- 10
- 试验地点
- 1
- 主要终点
- Number of participants experiencing an AE/SAE
研究概览
简要总结
The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects of non childbearing potential and/or male Japanese subjects between the ages of 20 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Subject must have four Japanese grandparents who were born in Japan.
- •Evidence of a personally signed and dated informed consent document.
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
- •Smoking cigarettes with exceeding provided criteria.
- •History of regular alcohol consumption exceeding provided limitations.
- •Treatment with an investigational drug within a provided criteria.
- •Abnormal supine blood pressure.
- •Abnormal pulse rate.
- •Abnormal 12 lead ECG.
- •History of tuberculosis.
- •History of hepatitis or positive testing for HIV, hepatitis B surface antigen, hepatitis B surface antibodies, hepatitis B core antibodies, hepatitis C antibodies or syphilis.
- •Any medical history of disease (ie, Gilbert's disease).
- •Abnormal clinical laboratory test related to cardiac and skeletal muscle injury.
- •Male subjects with partners currently pregnant; unwilling or unable to use a highly effective method of contraception
- •Use of prescription or nonprescription drugs, vitaminic and dietary supplements within a specified duration.
- •Blood donation exceeding a provided limitation.
- •History of sensitivity to heparin or heparin induced thrombocytopenia.
- •History of cancer (other than treated basal cell and squamous cell carcinoma of the skin) in the previous 5 years.
- •Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- •Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
300 mg
Experimental
干预措施: PF-06650833 (Drug)
结局指标
主要结局
Number of participants experiencing an AE/SAE
时间窗: Day 18
次要结局
- Clearance(Day 10)
- Mean residence time(Day 10)
- Volume of distribution(Day 10)
- Time to peak concentration(Day 1 and Day 10)
- Minimum plasma concentration (Cmin)(Days 2, 4, 7 and 10)
- Fluctuation ratio (Cmax:Cmin)(Day 10)
- Maximum plasma concentration (Cmax)(Day 1 and Day 10)
- Area under the plasma concentration time curve for dosing interval (AUCtau)(Day 1 and Day 10)
- Observed exposure accumulation ratio for AUCtau(Day 10)
- Observed exposure accumulation ratio for Cmax(Day 10)
- change from baseline in vital signs(Day 18)
- Incidence of treatment emergent clinical laboratory abnormalities(Day 18)
- change form baseline in electrocardiogram (ECG) parameters(Day 18)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Safety and Tolerability of PF-06818883 in Healthy SubjectsHealthyNCT03020784Pfizer30
已完成
1 期
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult SubjectsHealthy VolunteersNCT02539550Pfizer25
已完成
1 期
A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic RhinitisAllergic RhinitisNCT01723254Pfizer190
已完成
1 期
Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult SubjectsHealthyNCT03599063Pfizer63
已完成
1 期
Singe Dose Study of PF- 06946860 in Healthy Adult Japanese ParticipantsHealthyNCT03974776Pfizer8