Phase 1 Open-Label Randomized 4 Period Crossover Study Comparing Safety, Tolerability and PK of Ondansetron Given Subcutaneously With Hylenex Recombinant and Given Alone Intramuscularly, Intravenously and Orally in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of Overall Safety
研究概览
简要总结
This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers.
详细描述
This is a randomized, open label, 4 way crossover Phase 1 study of the pharmacokinetics, safety and tolerability of a 4 mg dose of ondansetron administered subcutaneously with Hylenex recombinant compared to 4 mg doses of ondansetron administered intravenously and intramuscularly and an 8 mg dose of ondansetron administered orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers 19-65 years old
- •Females must be nonlactating and nonpregnant (negative serum pregnancy test at screening)and agree to practice effective birth control for at least 30 days after study completion
- •Nonsmoker or no tobacco/nicotine use in previous 6 months
- •Intact normal skin without obscuring tattoos, pigmentation or lesions
- •Adequate venous access in upper extremities
- •Normal vital signs, ECG, and labs or assessed by the Investigator as NCS
- •Serum hemoglobin within site's normal range
- •Negative drug and alcohol screen
- •Able to make decisions and comply with study requirements
排除标准
- •History of drug or alcohol abuse or positive drug and alcohol screen
- •Abdominal surgery within the last 30 days
- •Phenylketonuria
- •Tobacco or nicotine use within previous 6 months
- •Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor agonists
- •Received ondansetron within 4 days prior to Day 1
- •Known allergy to hyaluronidase or other ingredient in Hylenex recombinant
- •Lower extremity edema
- •Creatinine clearance < 60 mL/min
- •Dehydration (Grade 2 or higher)
- •Hypersensitivity or contraindication to heparin
- •Abnormal ECG with clinically significant QT prolongation or history of
- •Female who is pregnant or breastfeeding
- •Participation in a clinical trial (drug or device) within 30 days of enrollment
- •Clinically significant medical history, major systemic disease, intercurrent illness, physical examination finding, or clinical laboratory test result that risks the subject's safety or interfere with interpretation of study results
- •Not able to comply with study requirements
研究组 & 干预措施
Subcutaneous Administration
Ondansetron + Hylenex administered subcutaneously
干预措施: Ondansetron + Hylenex (Drug)
Oral Administration
Ondansetron administered orally
干预措施: Zofran ODT (Drug)
Intramuscular Administration
Ondansetron administered intramuscularly
干预措施: Ondansetron (Drug)
Intravenous Administration
Ondansetron administered intravenously
干预措施: Ondansetron solution (Drug)
结局指标
主要结局
Evaluation of Overall Safety
时间窗: Days 1-31
Investigator assessment of infusion site observations for parenteral administration; Subject assessment of pain using the verbal response scale for parenteral administration; Subject assessment of pain using the visual analog scale for parenteral administration; Investigator assessment of systemic adverse events
次要结局
- Evaluation of Pharmacokinetics(Days 1-5)