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AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)

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.
 
ClinicalTrials.gov Identifier: NCT00912353
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD7268 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects
Study Start Date : May 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: AZD7268 Drug: AZD7268
Single Oral

Placebo Comparator: Placebo Drug: Placebo
Single Oral




Primary Outcome Measures :
  1. To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings, [ Time Frame: From screening period to follow-up, 44 days (maiximum). ]

Secondary Outcome Measures :
  1. To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine. [ Time Frame: Blood and urine sampling from pre-dose until 72 hrs post dose. ]
  2. To collect and store DNA for future exploratory research [ Time Frame: One blood sampling after randomisation ]


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:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
  • Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)

    • 18 to ≤ 27 kg/m2

Exclusion Criteria:

  • Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
  • Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
  • Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

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 ClinicalTrials.gov identifier (NCT number): NCT00912353


Locations
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United States, California
Research Site
Gelndale, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Mark Yen, MD California Clinical Trials
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00912353    
Other Study ID Numbers: D1151C00002
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: August 2010
Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD7268