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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741689

D1020C00003

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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36 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: AZD1656