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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00721448
First received: July 22, 2008
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Pharmacokinetics
Drug: AZD6140
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: July 22, 2008
Last Updated: December 2, 2010
Health Authority: China: Ethics Committee
China: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014