A Phase I,Single-Center,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects

AstraZeneca1 site in 1 country48 target enrollmentOctober 2008

ConditionsHealthy Volunteer

InterventionsAZD7325 Placebo

DrugsAZD7325 Placebo

Overview

Phase: Phase 1
Intervention: AZD7325
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 48
Locations: 1
Primary Endpoint: Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

March 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Body mass index (BMI) : 18 to 27 kg/m 2

Exclusion Criteria

•Clinically relevant disease and/or abnormalities (past or present)
•Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
•Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
•Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

Arms & Interventions

1

Intervention: AZD7325

2

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.

Time Frame: During the study

Secondary Outcomes

Pharmacokinetic parameters for AZD7325(During residential period)
Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.(During the study)