A PHASE 1, OPEN-LABEL, SINGLE-ARM, SINGLE DOSE AND MULTIPLE DOSES STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN CHINESE HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration time profile from time zero to time tau
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of PF-04965842 after single dose and once-daily multiple-doses in Chinese healthy participants.
详细描述
This is a Phase 1, open-label, single-arm, single- and multiple-dose study to assess the pharmacokinetics, safety and tolerability of PF-04965842 in Chinese healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 19 to 26 kg/m2; and a total body weight >50 kg.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
排除标准
- •Evidence or clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), 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 human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and serological reaction of syphilis. As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of participant vaccination is permissible.
- •Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
- •History of tuberculosis (TB) or active or latent or inadequately treated infection, positive QuantiFERON- TB Gold test or positive chest radiographs for active tuberculosis infection.
- •Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
- •History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
- •Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- •A positive urine drug test.
- •Screening sitting 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 ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 × upper limit of normal (ULN); Total bilirubin level >1 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <=1 × ULN.
研究组 & 干预措施
PF-04965842
Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or minus 2 hours in the morning. On Days 3 to 8, participants will receive PF-04965842 oral dose of 200 mg (2 × 100 mg tablets) QD in the morning at approximately similar clock hour as on Day 1. On Day 3 and Day 6-8, the dosing of PF-04965842 will be after collection of pre-dose blood samples (under fasted condition for at least 10 hours). On Day 8, the dosing will be under fasted condition at approximately 8:00 am plus or minus 2 hours in the morning.
干预措施: PF-04965842 (Drug)
结局指标
主要结局
Area under the plasma concentration time profile from time zero to time tau
时间窗: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 and Day8
PK parameters derived from plasma PF-04965842 concentration
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
时间窗: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1
PK parameters derived from plasma PF-04965842 concentration
Maximum Observed Plasma Concentration (Cmax)
时间窗: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1
PK parameters derived from plasma PF-04965842 concentration
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1
PK parameters derived from plasma PF-04965842 concentration
次要结局
- Number of Participants With Adverse Events (AEs)(Screening up to follow up (71 days))
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests(Screening up to follow up (71 days))
- Number of Pariticipants With Clinically Significant Change From Baseline in Vital Signs(Screening up to follow up (71 days))
- Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings(Screening up to follow up (71 days))