A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss

Biogen44 enrolled

Overview

The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

PF-04958242DRUG

PF-04958242 0.35 mg oral solution

PF-04958242DRUG

PF-04958242 0.27 mg oral solution

PlaceboDRUG

Placebo oral solution

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear. * Subjects must have symmetric hearing loss * Subjects who can read, speak and comprehend English. Exclusion Criteria: * Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss * Subjects who have hearing disorders other than age related sensorineural hearing loss * Subjects with moderate or greater tinnitus * Pregnant females; breastfeeding females; females of childbearing potential

Locations (11)

Pfizer Investigational Site

Anaheim, California, United States

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz

Time frame: 1 hour

Secondary Outcomes

Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz

Time frame: 5 hours

Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score

Time frame: 1 hour, 5 hours

Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing

Time frame: 1 hour, 5 hours

Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale

Time frame: 1 hour, 5 hours

Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.

Time frame: 45 min, 1 hour, 5 hours

Data from ClinicalTrials.gov

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