Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD2516; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754715

EudractCT: 2008-003598-42

D2080C00001

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
• Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion criteria

• History of previous or ongoing psychiatric disease.
• 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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72 participants in 2 patient groups, including a placebo group

AZD2516

Experimental group

Treatment:

Drug: AZD2516

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo