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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00726427

First received: July 29, 2008

Last updated: December 2, 2010

Last verified: December 2010

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AZD1656	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety variables (AE's, BP, pulse, lab variables, and ECG) [ Time Frame: Safety variables taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic variables [ Time Frame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	July 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726427

Locations

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Klas Malmberg, MD, PhD	AstraZeneca R&D Mölndal
Principal Investigator:	Sylvan Hurewitz, MD	AstraZeneca CPU, Philadelphia, PA

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00726427 History of Changes
Other Study ID Numbers:	D1020C00001
Study First Received:	July 29, 2008
Last Updated:	December 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

pharmacokinetics
pharmacodynamics
AZD1656

safety
tolerability
Healthy Volunteers

ClinicalTrials.gov processed this record on June 18, 2013