A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in 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: NCT00726427
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : December 3, 2010
Information provided by:

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: 1
8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group)
Drug: AZD1656
Dose escalation to achieve maximum tolerated dose
Experimental: 2
2 oral doses of AZD1656 given to 2 groups together with food
Drug: AZD1656
Oral single dose

Primary Outcome Measures :
  1. Safety variables (AE's, BP, pulse, lab variables, and 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

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.

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Provision of informed consent
  • 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 2 weeks before the first administration of the Investigational Product
  • 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): NCT00726427

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Study Director: Klas Malmberg, MD, PhD AstraZeneca R&D Mölndal
Principal Investigator: Sylvan Hurewitz, MD AstraZeneca CPU, Philadelphia, PA

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: NCT00726427     History of Changes
Other Study ID Numbers: D1020C00001
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Healthy Volunteers