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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00721448

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study
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

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:

90mg tablet, oral, once daily for the first day and twice daily from day 4 to 9

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

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

Responsible Party:	AstraZeneca Pharmaceuticals ( Marco Avila )
Study ID Numbers:	D5130C00054
Study First Received:	July 22, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00721448
Health Authority:	China: Ethics Committee; China: State Food and Drug Administration

Keywords provided by AstraZeneca:

Pharmacokinetics

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009