Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00738959
• Date of registration: 20/08/2008
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
• Scientific 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
• Date of first enrolment: June 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00738959
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Ulrike Lorch, MD
• Affiliation: Richmond Pharmacology Ltd St George's University of London Cranmer Terrace, TootingLondon SW17 ORE UK

• Name: Didier Meulien, MD
• Affiliation: AstraZeneca R&D Södertälje, Sweden

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: AZD0328

Primary Outcome(s)

Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements [Time Frame: During the whole treatment period]

Secondary Outcome(s)

PK variables [Time Frame: Several samples during the study days]

Secondary ID(s)

EUdract NO 2008-001723-56

D0190C00008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors