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SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

NCT02819856 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Ototoxicity

Interventions

DRUG

Placebo

0 mg SPI-1005 bid po x 21d

DRUG

SPI-1005 Ebselen 200mg Capsule x1

200 mg SPI-1005 bid po x21d

DRUG

SPI-1005 Ebselen 200mg Capsule x2

400 mg SPI-1005 bid po x 21d

DRUG

SPI-1005 Ebselen 200mg Capsule x3

600 mg SPI-1005 bid po x 21d

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Sound Pharmaceuticals, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jonathan Kil, MD · SOUND PHARMACEUTICALS, INC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2023-04-07
Completion
2023-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02819856 on ClinicalTrials.gov