This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered with a washout period of at least 1 week between the doses to investigate the relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations compared to the oral solution of AZD3293. The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the study. AZD3293 is being developed for the treatment of Alzheimer's disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
1
Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15.
Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15.
Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15.
Research Site
Cypress, California, United States
The relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulations and the oral solutio
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
Time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)
To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
Time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)
Safety profile in terms of Adverse events assessment
Time frame: From Baseline and up to day 25
Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)
Time frame: From Baseline and up to day 25
Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams
Time frame: From baseline and up to day 25
Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters
Time frame: from baseline and up until day 25
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