Bleeding Time Study With AZD6482, Clopidogrel and ASA

NCT00853450 | Completed Phase 1

• 2 other identifiers: D1700C00004EudraCT no. 2008-007030-21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antiplatelet Effect

Keywords

Antiplatelet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Pharmacokinetics

  Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion

• Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)

  Repeatedly during the study

Study Arms (2)

1

EXPERIMENTAL

AZD6482 on top of ASA

Drug: AZD6482; Drug: ASA

2

ACTIVE COMPARATOR

Clopidogrel on top of ASA

Drug: Clopidogrel; Drug: ASA

Interventions

AZD6482 DRUG

Single intravenous infusion during a maximum of 5 hours

1

Clopidogrel DRUG

Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.

Also known as: Plavix®

2

ASA DRUG

75 mg orally once daily during 7 days in each treatment arm

Also known as: Trombyl®

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Lund, Sweden

Location

MeSH Terms

Interventions

2-(1-(7-methyl-2-morpholin-4-yl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl)ethylamino)benzoic acid; Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Peter Held

  AstraZeneca Mölndal

  STUDY DIRECTOR

• Bo Fransson, MD

  AstraZeneca Clinical Pharmacology Unit, Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 19, 2009

Record last verified: 2009-08

Locations

SE (1)