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

AstraZeneca1 site in 1 country32 target enrollmentJuly 2008

ConditionsHealthy

InterventionsAZD1656

Overview

Phase: Phase 1
Intervention: AZD1656
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 32
Locations: 1
Primary Endpoint: Safety variables (AE's, BP, pulse, lab variables, and ECG)
Status: Completed
Last Updated: 15 years ago

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

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

September 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Factorial

Sex

Male

Sponsor

•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.

•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

8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group)

Intervention: AZD1656

2 oral doses of AZD1656 given to 2 groups together with food

Intervention: AZD1656

Safety variables (AE's, BP, pulse, lab variables, and ECG)

Time Frame: Safety variables taken repeatedly during 24 hours on study day sessions

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)