A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

Phase 1CompletedNCT02005211

AstraZeneca114 enrolled

Overview

This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

114

Conditions

Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers

Interventions

AZD3293DRUG

Oral solution

PlaceboDRUG

Oral solution

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Japanese elderly and young males and females (of non-childbearing potential) * Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg Exclusion Criteria: * Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders * Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs. * Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products. * Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.

Locations (1)

Research Site

Fukuoka, Japan

Outcomes

Primary Outcomes

Safety - Adverse Events

Safety - Number of subjects reporting any adverse events during the study

Time frame: Day of first dose to follow up

Secondary Outcomes

PK Cmax - Overall Study

Pharmacokinetic maximum concentration

Time frame: 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr

PK AUC - Overall Study (SAD & MAD Parts)

Pharmacokintic Area Under the Curve (0 to t)

Time frame: 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr

Biomarker

Biomarker (Abeta 1-40; A beta 1-42) % change from baseline

Time frame: Pre dose vs Day 14

Data from ClinicalTrials.gov

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