Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

Phase 1CompletedNCT00972049

AstraZeneca40 enrolled

Overview

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD2516DRUG

Capsule administered once orally. Specific dose depends on dose panel.

PlaceboDRUG

Capsule administered once orally

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2 * Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly) Exclusion Criteria: * History of previous or ongoing somatic or psychiatric disease/condition * Abnormalities in ECG that may interfere with interpretation of data.

Locations (1)

Research Site

Fukuoka, Japan

Outcomes

Primary Outcomes

Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG

Time frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3

Secondary Outcomes

Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects

Time frame: Blood sampling at defined timepoints during residential period and follow-up

Data from ClinicalTrials.gov

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