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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721448
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: AZD6140; Drug: AZD6140	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

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 [day -1, 4, 7, 10, 13+3~5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00721448
• Other Study ID Numbers: D5130C00054
• First Posted: Jul 24, 2008
• Last Update Posted: Dec 3, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Pharmacokinetics
• Additional relevant MeSH terms: Ticagrelor

Study Results

No Results Posted as of Dec 3, 2010