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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Drug: AZD6140

Study type

Interventional

Funder types

Industry

Identifiers

NCT00721448

D5130C00054

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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