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

Phase 1

Completed

• Conditions: Antiplatelet Effect
• Interventions: Drug: AZD6482; Drug: Placebo

• Registration Number: NCT00688714
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Last Update Submitted: 2008-05-30
• Study First Posted: 2008-06-03
• Last Update Posted: 2008-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD6482	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables	Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.

Secondary Outcome Measures

Name	Time	Method
Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index)	Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
Pharmacokinetics and inhibition of platelet aggregation	Prior to dose and repeatedly during 24 hrs after dose.