NCT01772264已完成1 期
An Investigator And Subject Blinded, Sponsor Open, Randomized, Placebo Controlled, Multiple Dose Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-05089771 In Healthy 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
- 40
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.
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
- 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 male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate
排除标准
- •Evidence or history of clinically significant hematological, renal (ie, recurrent nephrolitisis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •History of, or presence of allergic skin reactions or active skin disease (except for subjects with acne who may be included in the study) at the time of screening.
研究组 & 干预措施
Arm A - active treatment
Experimental
干预措施: PF-05089771 (Drug)
Arm B - placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 12h
Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: 28 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
时间窗: 12h
次要结局
- Minimum Observed Plasma Trough Concentration (Cmin)(12h post dose)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's DiseaseAlzheimer's DiseaseNCT01677572Biogen197
终止
1 期
Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788HealthyNCT02255968Enanta Pharmaceuticals, Inc16
已完成
1 期
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult VolunteersHealthyNCT02228707Biogen56
撤回
1 期
Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes MellitusType 1 Diabetes MellitusNCT05272059Novartis Pharmaceuticals
已完成
1 期
A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)Parkinson's DiseaseNCT04875962UCB Biopharma S.P.R.L.31