A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sensorion
• Treatments: Azasetron

Criteria

Main Inclusion Criteria:

Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study:

1. Adults aged 18 to 75 years;

2. 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;

3. 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:

1. Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min

2. 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

3. Unable or unwilling to comply with the protocol requirements

4. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction