A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese Subjects

AstraZeneca1 site in 1 country30 target enrollmentMay 2008

ConditionsHealthy Safety

InterventionsAZD2624 Placebo

DrugsAZD2624 Placebo

Overview

Phase: Phase 1
Intervention: AZD2624
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 30
Locations: 1
Primary Endpoint: To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

August 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Healthy young male Japanese volunteers

Exclusion Criteria

•Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1
•Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1
•Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1
•Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose

Arms & Interventions

1

Intervention: AZD2624

2

Intervention: Placebo

Outcomes

Primary Outcomes

To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs

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

Secondary Outcomes

Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624(A single blood sample will be obtained)
To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma(Blood samples will be taken before and after study drug administration.)