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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
History of Changes

August 25, 2008
December 2, 2010
August 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00741689 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers
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

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy Volunteers
Drug: AZD1656
Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose
Experimental: 1
AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group)
Intervention: Drug: AZD1656
Ericsson H, Röshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00741689
D1020C00003
Not Provided
Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Klas Malmberg, MD, PhD Prof AstraZeneca R&D Mölndal
Principal Investigator: Mark Yen, MD California Clinical Trials
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP