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

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ClinicalTrials.gov Identifier: NCT00688714
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Antiplatelet Effect Drug: AZD6482 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: 1 Drug: AZD6482
0,9-364,5 mg administrated through intravenous infusion over 3 hours

Placebo Comparator: 2 Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688714


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Marianne Hartford, MD AstraZeneca R&D, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göteborg, Sweden
Study Chair: Brian Bryzinski, MD AstraZeneca Wilmington, DE United States

Responsible Party: Brian Bryzinski, MD, Medical Science Director, Emerging Thrombosis, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier: NCT00688714     History of Changes
Other Study ID Numbers: D1700C00001
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: May 2008

Keywords provided by AstraZeneca:
Antiplatelet