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Completed

NCT Number: NCT00726427

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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of informed consent
  • 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 2 weeks before the first administration of the Investigational Product
  • 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 to achieve maximum tolerated dose

Primary outcomes

  1. Safety variables (AE's, BP, pulse, lab variables, and 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 Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 1, 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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