AZD8529 Multiple Ascending Dose Study in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AZD8529; Drug: Placebo

• Registration Number: NCT00765492
• Lead Sponsor: AstraZeneca

Brief Summary

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Study Completion: 2009-03
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-25
• Last Update Posted: 2009-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Female subjects must be of non-child bearing potential.

Exclusion Criteria

• Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod
• Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
• Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD8529	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.	each visit, at least daily, during the study.

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of AZD8529 in plasma	Blood samples will be taken during the study.