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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD7268; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Gelndale, California, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single Oral
Experimental: AZD7268	Drug: AZD7268; Single Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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,	From screening period to follow-up, 44 days (maiximum).

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 2, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): January 29, 2013
• Last Update Submitted That Met QC Criteria: January 28, 2013
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Phase I; Japanese healthy volunteer; AZD7268
• Other Study ID Numbers: D1151C00002