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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721448

Enrollment

Registered

2008-07-24

Start date

2008-06-30

Completion date

2008-08-31

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

Pharmacokinetics

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.

Interventions

DRUGAZD6140

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AZD6140 and AR-C124910XX concentration	-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

Measure	Time frame
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	day -1, 4, 7, 10, 13+3~5

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026