A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers
- Registration Number
- NCT00726427
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 AZD1656 8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group) 2 AZD1656 2 oral doses of AZD1656 given to 2 groups together with food
- Primary Outcome Measures
Name Time Method Safety variables (AE's, BP, pulse, lab variables, and 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
Related Research Topics
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Trial Locations
- Locations (1)
Research Site
🇺🇸Philadelphia, Pennsylvania, United States
Research Site🇺🇸Philadelphia, Pennsylvania, United States