NCT00456560已完成1 期
A Phase I, Randomized, Two-Period, Single-Center Study to Assess the Effect of CYP2D6 and CYP2C19 Inhibitors on a Single Oral Dose of AV650 (300 mg) in Healthy Subjects
Avigen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of AV650
研究概览
简要总结
The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on the way the body distributes, breakdowns and eliminates AV650. In addition, information about any side effects that may occur will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 to 29.9 kg/m2
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- •Clinical laboratory evaluations within the reference range for the test laboratory
- •Negative test for selected drugs of abuse at Screening
- •Negative HBsAg and HIV antibody screens
- •Females of childbearing potential must be surgically sterile, post-menopausal for at least one year, or using and effective method of contraception; females of child bearing potential must have a negative serum pregnancy test at Screening and Day -1
- •Males must be either sterile or agree to use an approved method of contraception
- •Able to comprehend and willing to sign an Informed Consent Form
排除标准
- •History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, psychiatric disorders, or cancer
- •History of inflammatory arthritis
- •History of symptomatic hypotension
- •History of severe physical injury, direct impact trauma, or neurological trauma within 6 months
- •History of seizure disorders
- •History of bipolar or major depressive disorder
- •History of hypersensitivity or allergies to any drug compound
- •Known intolerance to benzodiazepines
- •Known intolerance to active and/or inactive ingredients in fluvoxamine or paroxetine
- •History of stomach or intestinal surgery or resection, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
- •History or presence of an abnormal ECG
- •History of alcoholism, drug abuse, or drug addiction
- •Use of any nicotine-containing or nicotine-replacement products within 6 months of Day -1
- •Participation in any other investigational study drug trial within 90 days of Day -1
- •Use of any prescription medications/products within 3 months of Day 1 unless deemed acceptable by the PI
- •Received any vaccination or immunization within 1 month of Day -1
- •Use of any over-the-counter, non-prescription preparations within 7 days of Day -1
- •Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages with 72 hours of Day -1
- •Poor peripheral venous access
- •Donation of blood within 3 months of Day -1 or of plasma within 2 weeks of Screening
- •Receipt of blood products within 2 months of Day 1
- •Female subjects who are pregnant or nursing
- •Any acute or chronic condition that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study
结局指标
主要结局
Pharmacokinetics of AV650
次要结局
- Safety and tolerability of AV650
- Genetic contribution, if any, to AV650 metabolism
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?AutismNCT00655174The Hospital for Sick Children108
已完成
1 期
Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive DisorderHIV Associated Neurocognitive DisorderNCT01354314Johns Hopkins University45
尚未招募
不适用
Comparison of Drugs, Fluvoxamine and Fluoxetine in patients with OCD in terms of efficacy and effect on clinical and biochemical parameters.CTRI/2023/01/048722Government Medical College and Hospital, Chandigarh
已完成
1 期
A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy VolunteersHealthy VolunteerNCT01665404Hoffmann-La Roche16
已完成
1 期
Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on VentilationVentilatory DepressionHypercapniaNCT05470465Food and Drug Administration (FDA)27