A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sensorion
- 入组人数
- 28
- 试验地点
- 7
- 主要终点
- Proportion of Participants With SENS-401 Detected in Perilymph
研究概览
简要总结
The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.
详细描述
The study is a Phase IIa, open-label, randomized and controlled study investigating repeated twice-daily administration of oral SENS-401 in adult participants with moderately severe to profound hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment.
After written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (18 participants in Arm A and 9 participants in Arm B).
Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and up to 42 days from day of surgery inclusive.
Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study:
- •Adults aged from 18 years and older;
- •Meets the locally approved indication for cochlear implantation. The individual must have freely consented to the cochlear implant surgery before being offered to participate in the SENS-401-203 study;
- •Signed and dated written informed consent;
排除标准
- •Individuals will be excluded from the study if any of the following main exclusion criteria apply:
- •Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min
- •Any condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study
- •Unable or unwilling to comply with the protocol requirements
- •Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
研究组 & 干预措施
A, Treatment arm
Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days.
干预措施: SENS-401 (R-Azasetron Besylate) (Drug)
结局指标
主要结局
Proportion of Participants With SENS-401 Detected in Perilymph
时间窗: Day 8
A sample of perilymph was obtained from the round window during the cochlear implant surgery from Arm A participants only, after seven days of SENS-401. The percentage of participants with levels of SENS-401 in the perilymph above the Limit of Quantification was then calculated.
次要结局
- SENS-401 Perilymph Concentration(Day 8)
- SENS-401 Plasma Concentration(Day 8)
- Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies(Day 49 and Day 105)