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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD2516

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972049

D2080C00004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Capsule administered once orally

Treatment:

Drug: AZD2516

2

Placebo Comparator group

Description:

Capsule administered once orally

Treatment:

Drug: Placebo