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A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00741689
First received: August 25, 2008
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects


Condition Intervention Phase
Healthy Volunteers
Drug: AZD1656
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Oral Doses of AZD1656 in Japanese Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG) [ Time Frame: Safety variables taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
  • Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group)
Drug: AZD1656
Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese males aged ≥20 and ≤40 years of age
  • Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
  • History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator.
  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: NCT00741689

Locations
United States, California
Research Site
Glendale, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, PhD Prof AstraZeneca R&D Mölndal
Principal Investigator: Mark Yen, MD California Clinical Trials
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00741689     History of Changes
Other Study ID Numbers: D1020C00003
Study First Received: August 25, 2008
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Japanese
healthy
volunteers

ClinicalTrials.gov processed this record on November 23, 2014