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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688714
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE May 30, 2008
First Posted Date  ICMJE June 3, 2008
Last Update Posted Date June 3, 2008
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • 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. ]
  • Pharmacokinetics and inhibition of platelet aggregation [ Time Frame: Prior to dose and repeatedly during 24 hrs after dose. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate Safety and Tolerability of a Single Dose of AZD6482
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Antiplatelet Effect
Intervention  ICMJE
  • Drug: AZD6482
    0,9-364,5 mg administrated through intravenous infusion over 3 hours
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: AZD6482
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2008)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00688714
Other Study ID Numbers  ICMJE D1700C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian Bryzinski, MD, Medical Science Director, Emerging Thrombosis, AstraZeneca R&D Mölndal, Sweden
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP