Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529

AstraZeneca1 site in 1 country58 target enrollmentSeptember 2008

ConditionsHealthy Volunteer

InterventionsAZD8529 Placebo

DrugsAZD8529 Placebo

Overview

Phase: Phase 1
Intervention: AZD8529
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 58
Locations: 1
Primary Endpoint: To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

March 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Healthy male or female subjects aged 18 to 45 years (inclusive) on Day
•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 3 months 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 single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.

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

Secondary Outcomes

To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.(Safety assessments and blood and urine samples will be taken throughout the study.)
To characterize the pharmacokinetics of AZD8529 in plasma and urine.(Blood and urine samples will be taken during the study.)