NCT01173536已完成1 期
A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Parallel-Group Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female 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
- 入组人数
- 61
- 主要终点
- The QTcF (QT interval corrected by Fridericia's correction method)
研究概览
简要总结
This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, over 45 years of age
- •In good health, as determined by the absence of clinically significant findings from the screening visit
- •Body mass index between 18 and 32 kg/m^2 inclusive, with a body weight > 45 kg
- •Of non-childbearing potential
排除标准
- •History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis
- •Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
- •Personal or family history of congenital long QT syndrome or family history of sudden death
- •Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study
研究组 & 干预措施
C
Experimental
干预措施: GDC-0449 (Drug)
A
Active Comparator
干预措施: placebo (Drug)
B
Active Comparator
干预措施: placebo (Drug)
C
Experimental
干预措施: placebo (Drug)
A
Active Comparator
干预措施: moxifloxacin (Drug)
B
Active Comparator
干预措施: moxifloxacin (Drug)
结局指标
主要结局
The QTcF (QT interval corrected by Fridericia's correction method)
时间窗: Throughout study or until early discontinuation
次要结局
- Incidence, nature and severity of adverse events(Throughout study or until early discontinuation)
- Pharmacokinetic parameters of GDC-0449(Throughout study or until early discontinuation)
- Change in ECG from baseline(Throughout study or until early discontinuation)
研究者
相似试验
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for SuspensionRespiratory Syncytial Virus InfectionsNCT06328400Vigonvita Life Sciences24
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male VolunteersHealthyNCT03364985Daewoong Pharmaceutical Co. LTD.123
已完成
1 期
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult VolunteersHealthy VolunteersNCT03936166Crinetics Pharmaceuticals Inc.57
已完成
1 期
A Study of Multiple Ascending Doses MY008211A in Healthy AdultsParoxysmal Nocturnal HemoglobinuriaNCT05828472Wuhan Createrna Science and Technology Co., Ltd40
终止
1 期
A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199AnalgesiaNCT03880487Kalyra Pharmaceuticals, Inc.26