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

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.

Study Overview

• Status: Terminated
• Conditions: Thrombin Inhibition
• Intervention / Treatment: Drug: AZD8165

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD8165; Oral suspension, 2 mg/mL and 20 mg/mL, single doses

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Ralph Schutz, MD, Quintiles, Inc.; Study Director: Peter Held, AstraZeneca

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): September 17, 2010
• Last Update Submitted That Met QC Criteria: September 16, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: healthy; First time in man; thrombin inhibitor
• Other Study ID Numbers: D2890C00001