Study to Investigate Safety and Tolerability of a Single Dose of AZD6482 - Full Text View

Purpose

AZD6482 is a new drug substance aiming to prevent blood clots which may arise in atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and eliminated from the body will also be studied. This will be done by comparing the effect of single ascending doses of AZD6482 to placebo (inactive substance).

Condition	Intervention	Phase
Antiplatelet Effect	Drug: AZD6482 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Assess the Tolerability, Safety, Pharmacokinetic, and Pharmacodynamic Properties of AZD6482, Alone and co-Administered With ASA, After Single Ascending Intravenous Doses to Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables [ Time Frame: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index) [ Time Frame: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after. ] [ Designated as safety issue: No ]
Pharmacokinetics and inhibition of platelet aggregation [ Time Frame: Prior to dose and repeatedly during 24 hrs after dose. ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: AZD6482 0,9-364,5 mg administrated through intravenous infusion over 3 hours
Placebo Comparator: 2	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
Provision of written informed consent

Exclusion Criteria:

Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until administration of investigational product or clinically significant abnormalities in clinical chemistry, haematology, faeces, urinalysis or supine BP or pulse
Known impaired glucose intolerance or known or suspected Gilbert´s syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688714

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Marianne Hartford, MD	AstraZeneca R&D, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göteborg, Sweden
Study Chair:	Brian Bryzinski, MD	AstraZeneca Wilmington, DE United States

More Information

No publications provided

Responsible Party:	Brian Bryzinski, MD, Medical Science Director, Emerging Thrombosis, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier:	NCT00688714 History of Changes
Other Study ID Numbers:	D1700C00001
Study First Received:	May 30, 2008
Last Updated:	May 30, 2008
Health Authority:	Sweden: Medical Products Agency Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Antiplatelet

ClinicalTrials.gov processed this record on May 16, 2013