Bleeding Time Study With AZD6482, Clopidogrel and ASA

Antiplatelet Effect Clinical Trial

Official title:

A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853450
• Other study ID #: D1700C00004
• Secondary ID: EudraCT no. 2008
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2009
• Last updated: August 18, 2009
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antiplatelet Effect

Intervention

Drug:
• AZD6482
Single intravenous infusion during a maximum of 5 hours
• Clopidogrel
Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.
• ASA
75 mg orally once daily during 7 days in each treatment arm

Locations

Country	Name	City	State
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary Bleeding Time (CBT)		Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B	No
Secondary	Effect on bleeding		Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B	No
Secondary	Pharmacokinetics		Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion	No
Secondary	Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)		Repeatedly during the study	Yes