Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01150812

Enrollment

Registered

2010-06-25

Start date

2010-06-30

Completion date

2010-08-31

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombin Inhibition

Keywords

First time in man, healthy, thrombin inhibitor

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.

Interventions

DRUGAZD8165

Oral suspension, 2 mg/mL and 20 mg/mL, single doses

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026