A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to Young Healthy Male Japanese Subjects

AstraZeneca1 site in 1 country36 target enrollmentMay 2009

ConditionsHealthy

InterventionsAZD0837 Placebo

DrugsAZD0837 Placebo

Overview

Phase: Phase 1
Intervention: AZD0837
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 36
Locations: 1
Primary Endpoint: To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

June 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion Criteria

•Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
•Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
•Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

Arms & Interventions

1

Low dose

Intervention: AZD0837

2

Middle dose

Intervention: AZD0837

3

High dose

Intervention: AZD0837

4

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.

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

Secondary Outcomes

To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.(Blood samples will be taken before and after study drug administration.)