Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
研究概览
简要总结
This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.
详细描述
Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment;
- •Voluntarily consent to participate in the study;
- •Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
- •Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or
- •IUD in place for at least 3 months prior to study through study completion; or
- •Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or
- •Stable hormonal contraceptive for at least 3 months prior to study through study completion; or
- •Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
- •Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.
排除标准
- •Current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide);
- •History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma;
- •History of middle ear or inner ear surgery;
- •Current conductive hearing loss or middle ear effusion;
- •Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease;
- •History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
- •Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes;
- •Participation in another investigational drug or device study within 90 days prior to study enrollment;
- •Female patients who are pregnant or breastfeeding.
研究组 & 干预措施
Low dose
200 mg SPI-1005 bid po x 21d
干预措施: SPI-1005 (Drug)
Mid dose
400 mg SPI-1005 bid po x 21d
干预措施: SPI-1005 (Drug)
High dose
600 mg SPI-1005 bid po x 21d
干预措施: SPI-1005 (Drug)
Placebo
0 mg SPI-1005 bid po x 21d
干预措施: SPI-1005 (Drug)
结局指标
主要结局
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
时间窗: 7 weeks
Incidence of of Treatment-Emergent Adverse Events
Incidence of of Treatment-Emergent Adverse Events
时间窗: 7 weeks
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
次要结局
- Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing(7 weeks)
- Plasma Selenium levels before, during, and after 21 days of dosing(7 weeks)
- Pharmacodynamic response(7 weeks)
- Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing(21 days)
- Impact on Sensorineural Hearing Loss(7 weeks)
- Impact on Speech Discrimination(7 weeks)
- Impact on Tinnitus(7 weeks)
- Impact on Vertigo(7 weeks)
- Plasma Selenium Levels(7 weeks)