Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Japanese subjects with suitable veins for cannulation or repeated venepuncture.

• Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg

• Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

• Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.

• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator