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

AstraZeneca0 sites47 target enrollmentOctober 2008

ConditionsHealthy Volunteer

InterventionsAZD8529 Placebo

DrugsAZD8529 Placebo

Overview

Phase: Phase 1
Intervention: AZD8529
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 47
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

March 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

1

Intervention: AZD8529

2

Intervention: Placebo

Outcomes

Primary Outcomes

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.

Time Frame: each visit, at least daily, during the study.