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NCT Number: NCT00721448

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

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6140

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 24, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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