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

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A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss (version 1.0) - To examine the safety and effects on hearing thresholds of two single-doses of PF-04958242.

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From the articles I've read, there's some optimism within the pharmaceuticals industry regarding this compound. I can't seem to find much information on it, which isn't surprising given that there may be intellectual property concerns involved here. This is a Phase 1 trial, and Pfizer typically doesn't reveal modes of action for an investigative compound until phase 3 trials (according to their drug pipeline release I read). It will be interesting to see where this goes, seeing as how it's aim is to measure changes in hearing thresholds for severely hearing impaired individuals (I'm assuming this is because they want to be sure there is a quantifiable improvement, as opposed to a qualitative or subjective one).

 

I have heard of this trial but one of the exclusions is those with moderate or severe tinnitus. Intrigued by it nonetheless.

 

My guess that would be because moderate or severe tinnitus can interfere with your ability to have a purely objective tonal audiogram. Effects on tinnitus are one of the efficacy measures, actually.

 

thanks, interesting, cant find much info on it other than its an anti-pyschotic?
http://www.chemspider.com/Search.aspx?q=PF-04958242

 

It appears that it's listed by Pfizer as investigative for use in schizophrenia as well. That doesn't tell us much about the compound though. We'll probably have to wait until it gets to phase 3 trials (if it does) and if it doesn't, we'll probably never find out what compound it is.

 

It seems like this trial has closed now. I doubt Pfizer's going to be plastering results up on the web anytime soon though.

It would be interesting to see how this performed, although it was a phase 1 trial.

 

A pipeline report by pfizer no longer has hearing loss as an investigational indication for this compound, only schizophrenia now. I would assume that means it didn't work.

 

Just to recall the reference of this clinical trial:
https://clinicaltrials.gov/ct2/show/NCT01518920
Status: still completed. Study completion date: February 2013

See the protocol in the attached file.

Results:

See the link below for a laconic and ambiguous summary about the results:
https://www.ncbi.nlm.nih.gov/pubmed/25997115

See also the link below (excerpt of the book “Comprehensive Medicinal Chemistry III”):
https://books.google.fr/books?id=iZHUDQAAQBAJ&pg=RA4-PA450&lpg=RA4-PA450&dq=A+Study+Of+The+Effects+Of+PF-04958242+In+Subjects+With+Age-Related+Hearing+Loss&source=bl&ots=PaIbzXaODJ&sig=jW2j-r12Efs5UFO9nj7gJS5hlyc&hl=fr&sa=X&ved=0ahUKEwiJy7v667XWAhUEIsAKHfR_CvEQ6AEIUTAG#v=onepage&q=A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss&f=false
Page 450 : “the results of one study with PF-04958242 have been published, where it failed to show beneficial effects in treating age-related hearing loss”

See results in the other attached file (page 6).

No further information on Pfizer’s website:
http://www.pfizer.com/science/find-a-trial/detail/NCT01518920