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

NCT00721448 | Completed Phase 1

• 1 other identifier: D5130C00054
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (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 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

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

Interventions

AZD6140 DRUG

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese ethnicity defined as having both parents and 4 grandparents who are Chinese
• Have a normal Body size and weigh at least 50 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Beijing, China

Location

Related Publications (1)

• Li H, Butler K, Yang L, Yang Z, Teng R. Pharmacokinetics and tolerability of single and multiple doses of ticagrelor in healthy Chinese subjects: an open-label, sequential, two-cohort, single-centre study. Clin Drug Investig. 2012 Feb 1;32(2):87-97. doi: 10.2165/11595930-000000000-00000.

  PMID: 22168538 DERIVED

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Stephen Gillette

  AZ Pharmaceuticals - US

  STUDY DIRECTOR

• Li Haiyan, MD

  3rd hospital affiliated to Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

CN (1)