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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00726427

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD1656 Drug: AZD1656	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group)	Drug: AZD1656 Dose escalation to achieve maximum tolerated dose
Experimental: 2 2 oral doses of AZD1656 given to 2 groups together with food	Drug: AZD1656 Oral single dose

Arm

Intervention/Treatment

Experimental: 1

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

Drug: AZD1656

Dose escalation to achieve maximum tolerated dose

Experimental: 2

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

Drug: AZD1656

Oral single dose

Outcome Measures

Primary Outcome Measures

Safety variables (AE's, BP, pulse, lab variables, and ECG) [Safety variables taken repeatedly during 24 hours on study day sessions]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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