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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00741689

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Factorial Assignment, Safety/Efficacy Study
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
1: Experimental 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

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

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

Responsible Party:	AstraZeneca Pharmaceuticals ( Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products )
Study ID Numbers:	D1020C00003
Study First Received:	August 25, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00741689
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Japanese
healthy
volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009