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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 1, 2009
Last updated: January 28, 2013
Last verified: August 2010
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 Intervention Phase
Drug: AZD7268
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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. ]
  • To collect and store DNA for future exploratory research [ Time Frame: One blood sampling after randomisation ]

Enrollment: 56
Study Start Date: May 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD7268 Drug: AZD7268
Single Oral
Placebo Comparator: Placebo Drug: Placebo
Single Oral


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00912353

United States, California
Research Site
Gelndale, California, United States
Sponsors and Collaborators
Principal Investigator: Mark Yen, MD California Clinical Trials
  More Information

Responsible Party: AstraZeneca Identifier: NCT00912353     History of Changes
Other Study ID Numbers: D1151C00002
Study First Received: June 1, 2009
Last Updated: January 28, 2013

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD7268 processed this record on April 28, 2017