Clinical trial NCT02793232
Conditions: Healthy Subjects
Keywords: Safety Tolerability Pharmacokinetics Alzheimer's disease
Sponsor: Pfizer
Start date: 2016-06-13; Completion date: 2017-01-05
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will test the safety, tolerability and blood concentrations of single and multiple oral doses of PF-06751979 in health subjects and healthy elderly subjects. PF-06751979 is being developed for the treatment of Alzheimer's disease.

Detailed description:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of PF-06751979 following oral doses in healthy adult and healthy elderly subjects at higher doses than previously administered. Such characteristics will enable the design of future clinical trials in patient population, in the effort to optimize the efficacy of PF-06751979, as well as to establish safety margins in humans. Inclusion of healthy elderly subjects will be optional, but can provide additional safety and tolerability information in the age range of the target population while confirming the PK of PF-06751979 in these subjects for future clinical trials in the Alzheimer's disease patient population.

The Primary Objective is to evaluate the safety and tolerability of single and multiple ascending oral doses of PF-06751979 in healthy adult subjects. Secondary Objectives are to characterize the pharmacokinetics of PF-06751979 in: plasma following single and multiple ascending oral dose administration in healthy adult subjects and urine following multiple ascending oral dose administration in healthy adult subjects. An additional secondary objective is to evaluate the effect of multiple oral doses of PF 06751979 on CSF A-beta fragments in healthy adult subjects.

This study is divided into three parts: Part A - Single ascending doses (SAD) healthy adult subjects (18-55 years); Part B - Multiple ascending doses (MAD) in healthy adult subjects (18-55 years); Part C - Multiple doses (MD) in healthy elderly subjects (60-85 years). Study Parts may be run in a staggered fashion; Part C of the study may commence after satisfactory review of relevant data from Parts A and B.

Arms: arm 1: Single Ascending Dose in 4-way cross-over design (PF-06751979/Placebo). arm 2: Multiple dose administration to Healthy Subjects in parallel cohorts (PF-06751979). arm 3: Multiple dose administration to Healthy Elderly Subjects (PF-06751979). This cohort is optional.
Interventions: intervention 1: PF-06751979 single dose intervention 2: Placebo single dose intervention 3: PF-06751979 multiple ascending dose intervention 4: Placebo multiple ascending dose intervention 5: PF-06751979 multiple dose intervention 6: Placebo multiple elderly dose
Intervention descriptions: intervention 1: PF-06751979 administered as a single dose suspension in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF 06751979). The planned dose levels are 200 mg, 400 mg, 700 mg, 200 mg fed (these doses are subject to change based on emerging data). intervention 2: Matched Placebo suspension administered as single dose intervention 3: PF-06751979 suspension administered daily for 14 consecutive days to parallel cohorts. The planned dose levels are mg, 100 mg, 200 mg, 340 mg (these are subject to change based on emerging data). intervention 4: Matched placebo suspension administered daily for 14 consecutive days. intervention 5: PF-06751979 suspension administered daily for 14 consecutive days. The planned dose level is 340 mg (this is subject to change based on emerging data). intervention 6: Multiple dose administration to Healthy Elderly Subjects (Placebo)

Protocol documents: