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SPI-1005 for Prevention and Treatment of Aminoglycoside Induced Ototoxicity
The primary objective of this study is to determine the safety and tolerability of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE) reporting, hematology (CBC) chemistry (Chem-20). The secondary objectives of this study are to determine the pharmacokinetics of oral SPI-1005 at 200, 400 and 600 mg BID for 21 days. Peak/trough assessments will be determined for ebselen, its major metabolite and selenium. Clinical assessments of the severity of sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and lung function will be made compared between treatment arms and the placebo arm of this study.
18 Years and over
Phase 1/Phase 2
• 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.
• 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.
Drug: Placebo, Drug: SPI-1005 Ebselen 200mg Capsule x1, Drug: SPI-1005 Ebselen 200mg Capsule x2, Drug: SPI-1005 Ebselen 200mg Capsule x3