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OpenTrials
Completed

NCT Number: NCT00688714

Study to Investigate Safety and Tolerability of a Single Dose of AZD6482

AZD6482 is a new drug substance aiming to prevent blood clots which may arise in atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and eliminated from the body will also be studied. This will be done by comparing the effect of single ascending doses of AZD6482 to placebo (inactive substance).

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Key information

Conditions

Antiplatelet Effect

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

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 administration of investigational product or clinically significant abnormalities in clinical chemistry, haematology, faeces, urinalysis or supine BP or pulse
  • Known impaired glucose intolerance or known or suspected Gilbert´s syndrome

Treatment and study plan

AZD6482

Drug

0,9-364,5 mg administrated through intravenous infusion over 3 hours

Placebo

Drug

Primary outcomes

  1. General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables

    Time frame: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.

Secondary outcomes

  1. Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index)

    Time frame: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.

  2. Pharmacokinetics and inhibition of platelet aggregation

    Time frame: Prior to dose and repeatedly during 24 hrs after dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Assess the Tolerability, Safety, Pharmacokinetic, and Pharmacodynamic Properties of AZD6482, Alone and co-Administered With ASA, After Single Ascending Intravenous Doses to Healthy Male Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Jun 3, 2008

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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