NCT03020784终止1 期
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single-ascending Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-06818883 Following Single Intravenous Administration In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Physical examination
研究概览
简要总结
Safety, Tolerability and Pharmacokinetics of PF-06818883
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects of nonchildbearing potential and/or male subjects
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- •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 the placement of an intravenous drug administration line.
- •A confirmed positive urine drug screen
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement)
- •Screening supine blood pressure >140 mm Hg (systolic) or <90 mm Hg (diastolic), following at least 5 minutes of supine rest
- •Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.
- •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
- •History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb).
- •Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product
研究组 & 干预措施
Placebo
Placebo Comparator
IV placebo
干预措施: Placebo (Drug)
PF-06818883
Experimental
Experimental drug
干预措施: PF-06818883 (Drug)
结局指标
主要结局
Change in Physical examination
时间窗: Day 0, Day 1, Day 2 and Day 3
Safety test to check overall health
Change in 12-lead ECG (electrocardiogram)
时间窗: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
heart's electrical activity recorded from electrodes on the body surface
Change in Vital signs
时间窗: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions
Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
时间窗: Day 0, Day 2 and Day 3
Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Day 0, Day 1, Day 2, Day 3
An assessment of Adverse Events
Change in Neurological Exam
时间窗: Day 0, Day 1, Day 2 and Day 3
Assessment of sensory neuron and motor responses
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Clearance (CL) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Maximum Observed Plasma Concentration (Cmax) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Plasma Decay Half-Life (t1/2) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period(Day 1 hr, 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Volume of Distribution (Vss) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
- Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods(Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48)
研究者
研究点 (1)
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