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

Phase 1

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Drug: PF-04958242; Drug: Placebo

• Registration Number: NCT01518920
• Lead Sponsor: Biogen

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-04958242	PF-04958242	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Dallas, Texas, United States