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A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI) wit...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-005241-38

A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI) with a Lead-in, Open-Label, Single-Dose Relative Bioavailability Study of LX6171 Oral Suspension in Healthy Elderly Subjects

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Extrait

In stage A, the primary objective is: - To compare the relative bioavailability of a single dose of 300 mg LX6171 using a 40mg/mL and an 80mg/mL formulated suspension; - To evaluate plasma concentrations of LX6171 and its major metabolite LP-523122 after a single 300 mg administration of LX6171 oral suspension at two concentrations (40 mg/mL and 80 mg/mL), in order to determine doses to be utilized over a 28 day period (see stage B). In stage B, the primary objective is: - To evaluate the safety and tolerability of 2 dose levels LX6171 oral suspension when administered for 28 days, in subjects exhibiting AAMI

Critère d'inclusion

  • Age-Associated Memory Impairment (AAMI)

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