Clinical trial NCT00721448: An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: AZD6140 and AR-C124910XX concentration
timeFrame: -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 outcomes:
measure: 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
timeFrame: day -1, 4, 7, 10, 13+3~5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
Study officials:
affiliation: AZ Pharmaceuticals - US
name: Stephen Gillette
role: STUDY_DIRECTOR
affiliation: 3rd hospital affiliated to Peking University
name: Li Haiyan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.