Evaluation of the Presence of SENS-401 in the Perilymph

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hearing Loss

Intervention / Treatment
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* Drug: SENS-401 (R-Azasetron Besylate)


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: 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; Main Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, Treatment arm<br>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. | Drug: SENS-401 (R-Azasetron Besylate)<br>* Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.<br>|
| No Intervention: B, Control arm<br>Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SENS-401 perilymph detection percentage | Percentage of participants from Arm A with levels of SENS-401 in the perilymph above the Limit of Quantification on day of cochlear implant surgery after seven days of SENS-401. | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SENS-401 perilymph concentration | SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401. | Day 7 | 
| SENS-401 plasma concentration | SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401. | Day 7 | 
| Change of hearing threshold from baseline in the implanted ear at several frequencies | Change of hearing threshold from baseline in the implanted ear at several frequencies | Day 105 |