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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688714
First received: May 30, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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 Intervention Phase
Antiplatelet Effect
Drug: AZD6482
Drug: Placebo
Phase 1

Study Type: Interventional
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
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Pharmacokinetics and inhibition of platelet aggregation [ Time Frame: Prior to dose and repeatedly during 24 hrs after dose. ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD6482
0,9-364,5 mg administrated through intravenous infusion over 3 hours
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 30, 2008
Last Updated: May 30, 2008
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Antiplatelet

ClinicalTrials.gov processed this record on October 29, 2014