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

November 19, 2019 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06519
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06520-8071
        • Pfizer Investigational Site
    • Florida
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390-8575
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8868
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8891
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-9035
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo oral solution
Experimental: PF-04958242
Drug: PF-04958242
PF-04958242 0.35 mg oral solution
Drug: PF-04958242
PF-04958242 0.27 mg oral solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz
Time Frame: 5 hours
5 hours
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score
Time Frame: 1 hour, 5 hours
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
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
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
45 min, 1 hour, 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1701005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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