Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Thrombin Inhibition

Treatments: Drug: AZD8165

Study type: Interventional

Funder types: Industry

Identifiers

NCT01150812

D2890C00001

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

9 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD8165