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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00741689

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Aug 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG) [Safety variables taken repeatedly during 24 hours on study day sessions]

Secondary Outcome Measures

Pharmacokinetic variables [Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions]
Pharmacodynamic variables [Blood samples taken repeatedly during 24 hours on study day sessions]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00741689

Other Study ID Numbers:

D1020C00003

First Posted:

Aug 26, 2008

Last Update Posted:

Dec 3, 2010

Last Verified:

Dec 1, 2010

Keywords provided by , ,

Japanese

healthy

volunteers

Study Results

No Results Posted as of Dec 3, 2010