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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721448
• Other study ID #: D5130C00054
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2008
• Last updated: December 2, 2010
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• AZD6140
90mg tablet, oral, once daily for the first day and twice daily from day 4 to 9
• AZD6140
90 x 2 mg tablets, oral, once daily for the first day and twice daily from day 4 to 9

Locations

Country	Name	City	State
China	Research Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	Yes