Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Overview
- Phase
- Phase 2
- Intervention
- SPI-1005 Low dose
- Conditions
- Temporary Auditory Threshold Shift
- Sponsor
- Sound Pharmaceuticals, Incorporated
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Reduction in Temporary Threshold Shift
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen to music and take either the study drug, SPI-1005, or a placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects at the time of enrollment.
- •Each subject will give informed consent to participate in this study and agrees to the treatment protocol.
- •Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline).
- •Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study.
- •Subjects will have vital signs (i.e., heart rate, blood pressure, respirations, temperature) within normal limits upon medical examination.
- •Subjects must have normal audiologic assessment at baseline consisting of:
- •Baseline audiometric evaluation confirms that subjects have symmetric hearing with air conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies between 0.25 to 8 kilo Hertz (kHz) bilaterally.
- •No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any tested frequency.
- •No significant air-bone gaps (i.e. greater than 10 dB)
- •Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa) based on the 90% range for adults (Margolis and Hunter 2000)
Exclusion Criteria
- •• Subjects with abnormal hearing levels \> 25 dBHL at any tested frequency (250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear.
- •Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination.
- •Pathology of the external ear discovered upon otoscopic examination.
- •Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems.
- •Pathology of the inner ear or auditory nerve as revealed by reported history.
- •Subject complaints of aural pain, pressure, fullness, or drainage.
- •Subjects testing positive for pregnancy will be excluded from the study.
- •Subjects with other medical/health issues that would preclude voluntary participation in a drug study may be excluded at the discretion of the Principal Investigator.
- •Subjects that have previously received any known potentially ototoxic medication. This includes, but is not limited to, high dose salicylates (\>2 g/day), platinum-based chemotherapeutics and aminoglycoside antibiotics, such as streptomycin, gentamicin,tobramycin, amikacin, neomycin, and netilmycin.
- •Subjects that are currently using of any potentially ototoxic medications (i.e. diuretics or minocycline).
Arms & Interventions
SPI-1005 Low dose
200mg SPI-1005, capsule, bid, po, x4d
Intervention: SPI-1005 Low dose
SPI-1005 Middle Dose
400mg SPI-1005, capsule, bid, po, x4d
Intervention: SPI-1005 Middle dose
SPI-1005 High Dose
600mg SPI-1005, capsule, bid, po, x4d
Intervention: SPI-1005 High dose
Placebo
0mg SPI-1005, capsule, bid, po, x4d
Intervention: Placebo
Outcomes
Primary Outcomes
Reduction in Temporary Threshold Shift
Time Frame: 1 week
Post-sound exposure pure tone audiometry will be compared with baseline (i.e., immediately pre-sound exposure) testing to determine group mean level hearing threshold shift changes between treated and placebo groups.