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

Study Overview
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Brief Summary
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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.

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

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-04958242 In Subjects With Age-Related Sensorineural Hearing Loss

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Drug: PF-04958242
* Drug: PF-04958242
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04958242<br> | Drug: PF-04958242<br>* PF-04958242 0.35 mg oral solution<br>Drug: PF-04958242<br>* PF-04958242 0.27 mg oral solution<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz |  | 5 hours | 
| Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score |  | 1 hour, 5 hours | 
| Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing |  | 1 hour, 5 hours | 
| Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale |  | 1 hour, 5 hours | 
| Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose. |  | 45 min, 1 hour, 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age related sensorineural hearing loss, PF-04958242