Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: AZD8566; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00844103

D1320C00002

Details and patient eligibility

About

The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of written informed consent.
• Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
• Females who are permanently or surgically sterile or postmenopausal and males.

Exclusion criteria

• Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
• History of any convulsions or seizures
• History of infection or at risk of infection due to recent surgery or trauma
• History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD8566

2

Placebo Comparator group

Treatment:

Drug: Placebo