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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD1656

• Registration Number: NCT00741689
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	AZD1656	AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Glendale, California, United States