A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers

NCT ID: NCT01765868

Last Updated: 2023-08-08

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-10-31

Brief Summary

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This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single Arm Oral and IV Betrixaban

Group Type EXPERIMENTAL

Betrixaban

Intervention Type DRUG

Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose

Interventions

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Betrixaban

Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult men ages of 19 and 65 years old, inclusive
* BMI of 18-35 kg/m2

Exclusion Criteria

* Clinically significant comorbid disease
* History of substance abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Portola Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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07-012

Identifier Type: -

Identifier Source: org_study_id

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