AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD7268; Drug: Placebo

• Registration Number: NCT00912353
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-08
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD7268	AZD7268	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Gelndale, California, United States