AZD8529 Multiple Ascending Dose Study in Healthy Subjects

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8529 When Given as Single and Multiple Ascending Oral Doses in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: AZD8529

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD8529; oral
Placebo Comparator: 2	Drug: Placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
To characterize the pharmacokinetics of AZD8529 in plasma	Blood samples will be taken during the study.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Mark Smith, MD, PhD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 26, 2009
• Last Update Submitted That Met QC Criteria: June 25, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Phase I
• Other Study ID Numbers: D1960C00002