NCT01518920CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
PF-04958242
Experimental
Intervention: PF-04958242 (Drug)
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(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)
Investigators
Study Sites (1)
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