NCT02819856

SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of SPI-1005 in Cystic Fibrosis patients with Acute Pulmonary Exacerbation receiving intravenous tobramycin at risk for ototoxicity. All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.

Conditions

• Ototoxicity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-21
• Primary completion: 2023-04-07
• Completion: 2023-04-07
• First posted: 2016-06-30
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study