Study to Investigate Safety and Tolerability of a Single Dose of AZD6482

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

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).

Study Overview

• Status: Completed
• Conditions: Antiplatelet Effect
• Intervention / Treatment: Drug: Placebo; Drug: AZD6482

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD6482; 0,9-364,5 mg administrated through intravenous infusion over 3 hours
Placebo Comparator: 2	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables	Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.

Secondary Outcome Measures

Outcome Measure	Time Frame
Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index)	Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
Pharmacokinetics and inhibition of platelet aggregation	Prior to dose and repeatedly during 24 hrs after dose.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 3, 2008
• Last Update Submitted That Met QC Criteria: May 30, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Antiplatelet
• Other Study ID Numbers: D1700C00001