Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

Stopped early · Phase 1

Conditions studied: Thrombin Inhibition

In brief

The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.

Key facts

Study ID

NCT01150812

Run by

AstraZeneca

People needed

9

Starts

2010-06-01

Expected to finish

2010-08-01

Last updated by the study team

2010-09-17

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Suitable veins for cannulation or repeated venipuncture
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor more than 100 kg

You may not qualify if…

• History of any clinically significancy disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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