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COMPLETED
NCT02819856
PHASE2

SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

Sponsor: Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2017-07-21

Completion Date

2023-04-07

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States