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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 April 17, 2014