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An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00721448
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This will be a single centre study conducted at the 3rd hospital affiliated to Peking University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited to obtain at least 20 evaluable volunteers. The primary objective of this study is to characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese volunteers. The secondary objective of this study is to determine the safety and tolerability of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical examination, clinical laboratory tests, vital signs, and collection of adverse events in healthy Chinese volunteers.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: AZD6140 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Two-Cohort, Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Chinese Volunteers Living in China
Study Start Date : June 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor
U.S. FDA Resources


Intervention Details:
    Drug: AZD6140
    90mg tablet, oral, once daily for the first day and twice daily from day 4 to 9
    Drug: AZD6140
    90 x 2 mg tablets, oral, once daily for the first day and twice daily from day 4 to 9


Primary Outcome Measures :
  1. AZD6140 and AR-C124910XX concentration [ Time Frame: -2,0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours on days 4,5,6,7,8and 9. Day 10 the samples are at the specified timeframes (0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours) ]

Secondary Outcome Measures :
  1. determine the safety and tolerability of single and multiple doses of AZD6140 by physical examination, clinical laboratory tests, vital signs, and collection of adverse events [ Time Frame: day -1, 4, 7, 10, 13+3~5 ]


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:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese ethnicity defined as having both parents and 4 grandparents who are Chinese
  • Have a normal Body size and weigh at least 50 kg

Exclusion Criteria:

  • History of diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs determined by the investigator
  • Current and/or past history of intolerance or hypersensitivity to drugs with a similar chemical structure or mechanism of action to AZD6140 or any ingredient in its formulation
  • Symptoms of any clinically significant illness within 2 weeks of screening
  • A personal or family history of bleeding diatheses or a reasonable suspicion of vascular abnormalities including aneurysms

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): NCT00721448


Locations
China
Research Site
Beijing, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stephen Gillette AZ Pharmaceuticals - US
Principal Investigator: Li Haiyan, MD 3rd hospital affiliated to Peking University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Avila, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00721448     History of Changes
Other Study ID Numbers: D5130C00054
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Pharmacokinetics

Additional relevant MeSH terms:
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs