AZD0837 Extended Release (ER) Japan Study (ER J ph I)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00904800
First received: May 13, 2009
Last updated: July 10, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD0837
Drug: Placebo
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Blood samples will be taken before and after study drug administration. ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: May 2009
Study Completion Date: June 2009
Arms Assigned Interventions
Experimental: 1
Low dose
Drug: AZD0837
tablet, oral, once daily, 1+5 days
Experimental: 2
Middle dose
Drug: AZD0837
tablet, oral, once daily, 1+5 days
Experimental: 3
High dose
Drug: AZD0837
tablet, oral, once daily, 1+5 days
Placebo Comparator: 4
placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904800

Locations
Japan
Research Site
Kagoshima, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Hiroyuki Fukase, MD, PhD CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan
  More Information

No publications provided

Responsible Party: Wahlander Karin, MD, PhDMedical Science Director, AstraZeneca R&D Molndal
ClinicalTrials.gov Identifier: NCT00904800     History of Changes
Other Study ID Numbers: D1250C00055
Study First Received: May 13, 2009
Last Updated: July 10, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
Healthy volunteers

ClinicalTrials.gov processed this record on August 20, 2014