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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Antiplatelet Effect

Treatments: Drug: AZD6482; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688714

D1700C00001

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD6482

2

Placebo Comparator group

Treatment:

Drug: Placebo