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

August 7, 2023 updated by: Portola Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm Oral and IV Betrixaban
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of orally absorbed dose
Time Frame: over 72 hours
over 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portola Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 28, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimated)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Subjects

Clinical Trials on Betrixaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe