Bleeding Time Study With AZD6482, Clopidogrel and ASA

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Antiplatelet Effect

Treatments: Drug: Clopidogrel; Drug: AZD6482; Drug: ASA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853450

EudraCT no. 2008-007030-21

D1700C00004

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.

Enrollment: 28 estimated patients

Sex: Male

Ages: 18 to 50 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 the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
• Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

AZD6482 on top of ASA

Treatment:

Drug: ASA

Drug: AZD6482

2

Active Comparator group

Description:

Clopidogrel on top of ASA

Treatment:

Drug: ASA

Drug: Clopidogrel