A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of RP-1127 (Glyburide for Injection) in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events and Serious Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.
详细描述
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A healthy male or a healthy nonpregnant, nonlactating female.
- •Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
- •Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
- •A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
- •A negative urine or saliva test for selected substances of abuse and cotinine.
排除标准
- •Clinically significant history of hypoglycemia as assessed by the investigator.
- •History of seizure disorder, even if currently not receiving anticonvulsant medications.
- •History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
- •Be an active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Study Day
- •A history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable).
- •Use any prescription medication within 14 days prior to randomization, or nonprescription drugs within 7 days. Exceptions may be made by the medical monitor on a case-by-case basis.
- •Received another investigational drug within 30 days prior to randomization.
- •A positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test at screening. If the HIV test is positive, the subject will be informed privately and referred for additional counseling.
研究组 & 干预措施
Glyburide for Injection: Dose 1
Glyburide is administered as a bolus followed by a infusion for 72 hours
干预措施: Glyburide for Injection (Drug)
Matching Placebo
Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.
干预措施: Placebo (Drug)
Glyburide for Injection: Dose 2
Glyburide is administered as a bolus followed by a infusion for 72 hours
干预措施: Glyburide for Injection (Drug)
Glyburide for Injection: Dose 3
Glyburide is administered as a bolus followed by a infusion for 72 hours.
干预措施: Glyburide for Injection (Drug)
结局指标
主要结局
Number of Participants with Adverse Events and Serious Adverse Events
时间窗: Up to Day 28
An adverse event (AE) is defined as any untoward medical occurence such as a sign, symptom, and/or laboratory finding that is concurrent with the use of a drug in humans. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event
次要结局
- Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL)(Day 1 (baseline) and at multiple time points up to Day 5)
- Pharmacodynamic (PD) Parameter of Glyburide: Change from Baseline in Blood Glucose(Day 1 (baseline) and at multiple time points up to Day 5)
- PD Parameter of Glyburide: Change from Baseline in Serum Insulin(Day 1 (baseline) and at multiple time points up to Day 5)
- PK Parameter of Glyburide: Volume of Distribution (Vz)(Day 1 (baseline) and at multiple time points up to Day 5)
- PK Parameter of Glyburide: Elimination Rate Constant (λz)(Day 1 (baseline) and at multiple time points up to Day 5)
- PK Parameter of Glyburide: Half-Life (t1/2)(Day 1 (baseline) and at multiple time points up to Day 5)
- PK Parameter of Glyburide: Predicted Steady-State Concentration (Css)(Day 1 (baseline) and at multiple time points up to Day 5)
- PK Paramater of Metabolites (M1 and M2): Maximum Plasma Concentrations (Cmax)(Day 1 (baseline) and at multiple time points up to Day 5)