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Completed

NCT Number: NCT00853450

Bleeding Time Study With AZD6482, Clopidogrel and ASA

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.

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Key information

Conditions

Antiplatelet Effect

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6482

Drug

Single intravenous infusion during a maximum of 5 hours

clopidogrel

Drug

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

Other names: Plavix®

ASA

Drug

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

Other names: Trombyl®

Primary outcomes

  1. Capillary Bleeding Time (CBT)

    Time frame: 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

  1. Effect on bleeding

    Time frame: 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

  2. Pharmacokinetics

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

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

    Time frame: Repeatedly during the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Mar 2, 2009
Registry last updated
Aug 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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