Bleeding Time Study With AZD6482, Clopidogrel and ASA

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00853450

Enrollment

Registered

2009-03-02

Start date

2009-02-28

Completion date

2009-07-31

Last updated

2009-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiplatelet Effect

Keywords

Antiplatelet

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.

Interventions

DRUGAZD6482

Single intravenous infusion during a maximum of 5 hours

DRUGClopidogrel

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

DRUGASA

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026