Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The primary objective of this study is to determine the safety and efficacy of SPI-1005
treatment in CF patients with active pulmonary exacerbation that are receiving an IV course
of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK),
Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.
The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics
of SPI-1005.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Other
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.