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Completed

NCT Number: NCT00741689

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

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

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Key information

Conditions

Healthy Volunteers

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Glendale, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1656

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetic variables

    Time frame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions

  2. Pharmacodynamic variables

    Time frame: Blood samples taken repeatedly during 24 hours on study day sessions

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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