A Phase I, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Reach Maximum Plasma Concentration (Tmax) for Steady State
研究概览
简要总结
The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.
详细描述
A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
- •Total body weight >50 kilograms (kg) (110 pounds [lbs]);
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
- •Positive urine drug screen;
- •Pregnant or nursing females, and females of child bearing potential;
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Cohort 1
Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.
干预措施: PF-04958242 (Drug)
Cohort 2
Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.
干预措施: PF-04958242 (Drug)
Cohort 3
Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.
干预措施: PF-04958242 (Drug)
Cohort 4
Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.
干预措施: PF-04958242 (Drug)
Cohort 5
Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.
干预措施: PF-04958242 (Drug)
Cohort 6
Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.
干预措施: PF-04958242 (Drug)
Matching Placebo
Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Reach Maximum Plasma Concentration (Tmax) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose
时间窗: Day 1 and at multiple time points up to Day 17
Renal Clearance (CLr)
时间窗: Day 14
Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Elimination Half-Life (t1/2) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Maximum Observed Plasma Concentration (Cmax) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State
时间窗: Day 1 and at multiple time points up to Day 17
Percent of Dose Eliminated in Urine Unchanged (Ae%)
时间窗: Day 14
Amount of PF-04958242 Eliminated in Urine Unchanged (Ae)
时间窗: Day 14
Number of Participants Experiencing Adverse Events and Serious Adverse Events
时间窗: Baseline up to Day 23
An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Maximum Plasma Drug Concentration (Cmax) for Single Dose
时间窗: Day 1 and at multiple time points up to Day 17
Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose
时间窗: Day 1 and at multiple time points up to Day 17
次要结局
未报告次要终点