SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sound Pharmaceuticals, Incorporated
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics; Medical University of South Carolina
• Treatments: Ebselen

Criteria

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.