The study pharmacodynamic stopping criteria were met after the first dosing group
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
Sponsor study identifier
interventional
9
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 21, 2010
Actual (reported)June 25, 2010
Actual (reported)August 2010
Actual (reported)August 2010
Actual (reported)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.
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)
Oral suspension, 2 mg/mL and 20 mg/mL, single doses
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
Overland Park, Kansas, United States
Ralph Schutz, MD
Quintiles, Inc.
Peter Held
AstraZeneca
9 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2010
First Posted
June 25, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
September 17, 2010
Record last verified: 2010-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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