Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

Healthy Volunteers Clinical Trial

Official title:

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0328 in Healthy Young Japanese and Caucasian Male Volunteers After Oral Single and Multiple Ascending Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738959
• Other study ID #: D0190C00008
• Secondary ID: EUdract NO 2008-
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2008
• Last updated: October 28, 2008
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD0328
Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements		During the whole treatment period	Yes
Secondary	PK variables		Several samples during the study days	No