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

Antiplatelet Effect Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688714
• Other study ID #: D1700C00001
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2008
• Last updated: May 30, 2008
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Antiplatelet Effect

Intervention

Drug:
• AZD6482
0,9-364,5 mg administrated through intravenous infusion over 3 hours
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Pharmacokinetics and inhibition of platelet aggregation		Prior to dose and repeatedly during 24 hrs after dose.	No