A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

AstraZeneca1 site in 1 country48 target enrollmentMarch 2008

ConditionsHealthy Volunteer

InterventionsAZD7325

DrugsAZD7325

Overview

Phase: Phase 1
Intervention: AZD7325
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 48
Locations: 1
Primary Endpoint: To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
Status: Completed
Last Updated: 15 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 AZD7325 after single and repeated ascending doses.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

July 2008

Last Updated

15 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

•Clinically significant illness within 2 weeks before the study start.
•Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
•Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
•Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Arms & Interventions

1

Intervention: AZD7325

Outcomes

Primary Outcomes

To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs

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

Secondary Outcomes

Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses(Blood samples will be taken during the study.)
Evaluation of the pharmacodynamic effects of AZD7325(Test batteries will be performed at specified times both before and following study drug administration.)
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.(A single blood sample will be obtained.)