Study identifier:D5010C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Open-label, Randomized, Single-dose, 3-period Cross-over, Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
Healthy Volunteers, Pharmacologic action
Phase 1
Yes
AZD3293 oral solution, AZD3293 tablet formulation A, AZD3293 tablet formulation B
All
1
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Apr 2014 by AstraZeneca
AstraZeneca
-
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
Location
Location
Cypress, CA, United States
Arms | Assigned Interventions |
---|---|
Experimental: AZD3293 oral solution single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) | Drug: AZD3293 oral solution 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. Other Name: Beta secretase inhibitor |
Experimental: AZD3293 tablet formulation A single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) | Drug: AZD3293 tablet formulation A 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. Other Name: beta secretase inhibitor |
Experimental: AZD3293 tablet formulation B single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) | Drug: AZD3293 tablet formulation B 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. Other Name: Beta secretase inhibitor |
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