AZD0837 Extended Release (ER) Japan Study

Healthy Clinical Trial

— ER J ph I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904800
• Other study ID #: D1250C00055
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2009
• Last updated: July 10, 2009
• Start date: May 2009
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD0837
tablet, oral, once daily, 1+5 days
• Placebo
Placebo

Locations

Country	Name	City	State
Japan	Research Site	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.		All assessments are made at each visit, at least daily, during the study.	Yes
Secondary	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.	No