Clinical Trial Summary

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Phase

Phase 2

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Funding Agency/Sponsor

Industry

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Disease

Other

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Enrollment Eligibility

Inclusion Criteria:
- Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary
exacerbation.
- 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.
- Ability to perform all behavioral tests as indicated.
Exclusion Criteria:
- Current use or within 60 days prior to study enrollment the following IV ototoxic
medications: 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, hepatic, renal, hematologic, endocrine, immunologic, or
psychiatric disease.
- History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
- Participation in another investigational drug or device study within 30 days prior to
study enrollment.
- Female patients who are pregnant or breastfeeding.

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