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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00741689

Enrollment

Registered

2008-08-26

Start date

2008-08-31

Completion date

2008-12-31

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Japanese, healthy, volunteers

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

Interventions

DRUGAZD1656

Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026