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

July 22, 2008
December 2, 2010
June 2008
August 2008   (final data collection date for primary outcome measure)
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 ]
AZD6140 and AR-C124910XX concentration [ Time Frame: 2,0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours, day 4,5,6,7,8,9,10 (0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00721448 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pharmacokinetics
  • 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
Not Provided
Li H, Butler K, Yang L, Yang Z, Teng R. Pharmacokinetics and tolerability of single and multiple doses of ticagrelor in healthy Chinese subjects: an open-label, sequential, two-cohort, single-centre study. Clin Drug Investig. 2012 Feb 1;32(2):87-97. doi: 10.2165/11595930-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00721448
D5130C00054
No
Marco Avila, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Stephen Gillette AZ Pharmaceuticals - US
Principal Investigator: Li Haiyan, MD 3rd hospital affiliated to Peking University
AstraZeneca
December 2010

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