Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 67 of 914 for:    tablet | Japan

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00904800
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : July 13, 2009
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD0837 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : May 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904800


Locations
Layout table for location information
Japan
Research Site
Kagoshima, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Hiroyuki Fukase, MD, PhD CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan

Layout table for additonal information
Responsible Party: Wahlander Karin, MD, PhDMedical Science Director, AstraZeneca R&D Molndal
ClinicalTrials.gov Identifier: NCT00904800     History of Changes
Other Study ID Numbers: D1250C00055
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: July 13, 2009
Last Verified: July 2009

Keywords provided by AstraZeneca:
Phase I
Healthy volunteers