Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AZD0328

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738959

D0190C00008

EUdract NO 2008-001723-56

Details and patient eligibility

About

This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.

Enrollment: 64 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
• Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

Exclusion criteria

• History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
• Participation in another study within 12 weeks before the first administration of the investigational product.
• Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.

Trial design

64 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD0328