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

AstraZeneca1 site in 1 country40 target enrollmentApril 2009

ConditionsHealthy

InterventionsPlacebo AZD7268

DrugsAZD7268 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 40
Locations: 1
Primary Endpoint: To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses 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

Multiple Ascending Dose Study

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

October 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
•Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
•History of seizure (including infancy febrile seizures) or family history of seizure

Arms & Interventions

Placebo

Intervention: Placebo

AZD7268

Intervention: AZD7268

Outcomes

Primary Outcomes

To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses 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.(Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8)