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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00912353
First received: June 1, 2009
Last updated: January 28, 2013
Last verified: August 2010
  Purpose

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
Healthy
Drug: AZD7268
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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). ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • To collect and store DNA for future exploratory research [ Time Frame: One blood sampling after randomisation ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT00912353

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00912353     History of Changes
Other Study ID Numbers: D1151C00002
Study First Received: June 1, 2009
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD7268

ClinicalTrials.gov processed this record on August 28, 2014