PF-06648671 is a γ-secretase modulator being developed for the treatment of Alzheimer's disease. No preclinical information is publicly available on this compound.
From December 2014 to March 2015, Pfizer conducted a single-ascending-dose study in 18 healthy volunteers to assess routine safety and pharmacokinetic parameters, as well as measures related to the pharmacodynamics of plasma Aβ40 and Aβ42.
From May 2015 to October 2016, a second study enrolled 92 healthy elderly volunteers in Belgium for a two-week, once-daily regimen of ascending doses ranging from 4 to 100 mg of PF-06648671. The aim is to determine the maximum tolerated dose and assess drug interactions with the cytochrome P450 probe midalozam at that dose. Beside safety, pharmacokinetic, and pharmacodynamic measures of PF-06648671 in blood, CSF, and urine, additional outcome measures assess the change from baseline in CSF concentrations of Aβ 37, 38, 40, 42.
From October 2015 to March 2016, Pfizer enrolled 22 healthy volunteers in California to characterize the effect of single doses on the dynamics of CSF Aβ 37, 38, 40, 42, and Aβ total concentration using serial sampling of spinal fluid over 36 hours. This study used doses of 300 mg and lower.
In the fall of 2016, Pfizer is conducting a small drug interaction study with the CYP3A4 inhibitor itroconazole in 12 healthy volunteers.
For all trial listings on this drug, see clinicaltrials.gov.
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