A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

AstraZeneca1 site in 1 country48 target enrollmentDecember 2008

ConditionsHealthy Volunteer

InterventionsAZD7268 Placebo

DrugsAZD7268 Placebo

Overview

Phase: Phase 1
Intervention: AZD7268
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 48
Locations: 1
Primary Endpoint: To assess the safety and tolerability of single ascending dose administration of AZD7268 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 Sites Similar Trials

Overview

Brief Summary

Single Ascending Dose Study

Registry

clinicaltrials.gov

Start Date

December 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

•Provision of Informed Consent
•Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria

•Inability to understand or cooperate with given information
•Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
•Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Arms & Interventions

1

Intervention: AZD7268

2

Intervention: Placebo

Outcomes

Primary Outcomes

To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential.

Time Frame: Safety assessments are made at each visit, at least daily, during the study.

Secondary Outcomes

To characterize the pharmacokinetics of AZD7268 in plasma and urine.(Blood and urine samples will be taken during the study.)
To assess the effect of food on the safety and pharmacokinetic profile of AZD7268.(Safety assessments and blood and urine samples will be taken throughout the study.)