Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

Phase 1

Terminated

• Conditions: Thrombin Inhibition
• Interventions: Drug: AZD8165

• Registration Number: NCT01150812
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD8165	-

Primary Outcome Measures

Name	Time	Method
Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)	Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.

Secondary Outcome Measures

Name	Time	Method
Plasma and urine levels of AZD8165 and its active metabolite AZ12971554	Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554
Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time	Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States