A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

NCT ID: NCT02779192

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2021-10-31

Brief Summary

SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.

Detailed Description

Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.

Conditions

Noise Induced Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPI-1005 200 mg

200 mg SPI-1005, capsule, bid, po, x7d

Group Type: ACTIVE_COMPARATOR

SPI-1005 200mg

Intervention Type: DRUG

Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days

SPI-1005 400 mg

400 mg SPI-1005, capsule, bid, po, x7d

Group Type: ACTIVE_COMPARATOR

SPI-1005 400mg

Intervention Type: DRUG

Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days

Placebo

0 mg SPI-1005, capsule, bid, po, x7d

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days

Interventions

SPI-1005 200mg

Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days

Intervention Type: DRUG

SPI-1005 400mg

Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days

Intervention Type: DRUG

Placebo

Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days

Intervention Type: DRUG

Other Intervention Names

Low Dose; High Dose; Control

Eligibility Criteria

Inclusion Criteria

• Adult male or female patients, 18-50 years of age
• History of either recreational and/or occupational exposure to noise
• 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 intra-uterine device 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; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
• Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria

• Current use or within 60 days prior to study of excluded ototoxic medications
• History of autoimmune inner ear disease
• History of middle ear or inner ear surgery
• Current conductive hearing loss or middle ear effusion
• Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen
• Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
• Participation in another investigational drug or device study within 90 days prior to study enrollment
• Female patients who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sound Pharmaceuticals, Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Kil, MD

Role: STUDY_CHAIR

SOUND PHARMACEUTICALS, INC.

Locations

University of Miami

Miami, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

MUSC

Charleston, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

Sound Pharmaceuticals, Inc.

Seattle, Washington, United States

Countries

United States

Central Contacts

Jonathan Kil, MD

Role: CONTACT

jkil@soundpharma.com

2066342559

Facility Contacts

Michael Hoffer, MD

Role: primary

Hinrich Staecker, MD/PhD

Role: primary

Joe Kutz, MD

Role: primary

Other Identifiers

SPI-1005-203

Identifier Type: -

Identifier Source: org_study_id