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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01518920

Enrollment

Registered

2012-01-26

Start date

2011-12-31

Completion date

2013-02-28

Last updated

2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Sensorineural

Keywords

Age related sensorineural hearing loss, PF-04958242

Brief summary

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

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

Interventions

DRUGPF-04958242

PF-04958242 0.35 mg oral solution

DRUGPlacebo

Placebo oral solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026