Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00738959
First received: August 20, 2008
Last updated: October 28, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: AZD0328
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK variables [ Time Frame: Several samples during the study days ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD0328
Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738959

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition, AstraZeneca R&D, Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00738959     History of Changes
Other Study ID Numbers: D0190C00008, EUdract NO 2008-001723-56
Study First Received: August 20, 2008
Last Updated: October 28, 2008
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
AZD0328
Japanese
Caucasian
pharmacokinetics
safety
tolerability

ClinicalTrials.gov processed this record on April 17, 2014