Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00738959
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : October 29, 2008
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD0328 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : June 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: 1 Drug: AZD0328
Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

Primary Outcome Measures :
  1. 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 Measures :
  1. PK variables [ Time Frame: Several samples during the study days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00738959

United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Study Director: Didier Meulien, MD AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Ulrike Lorch, MD Richmond Pharmacology Ltd St George's University of London Cranmer Terrace, TootingLondon SW17 ORE UK

Responsible Party: Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition, AstraZeneca R&D, Södertälje, Sweden Identifier: NCT00738959     History of Changes
Other Study ID Numbers: D0190C00008
EUdract NO 2008-001723-56
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by AstraZeneca: