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

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. Identifier: NCT00741689
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : December 3, 2010
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Brief Summary:
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD1656 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions ]
  2. Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00741689

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals Identifier: NCT00741689     History of Changes
Other Study ID Numbers: D1020C00003
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca: