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Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

NCT ID: NCT01150812

Last Updated: 2010-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Thrombin Inhibition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD8165

Intervention Type DRUG

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

Interventions

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AZD8165

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Ralph Schutz, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Peter Held

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D2890C00001

Identifier Type: -

Identifier Source: org_study_id