NCT01765855

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

December 28, 2012

Last Update Submit

August 3, 2023

Conditions

Health Volunteers

Keywords

BetrixabanHealthyMass Balance

Outcome Measures

Primary Outcomes (1)

  • mean (max, tmax, AUC)

    Over 336 hours

Secondary Outcomes (1)

  • Percent dose recovered in urine and feces

    Over 336 hours

Study Arms (1)

Single Arm Oral Betrixaban

EXPERIMENTAL
Drug: Betrixaban single oral dose

Interventions

Betrixaban single oral doseDRUG
Single Arm Oral Betrixaban

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult men ages of 19 and 55 years old, inclusive
  • weighs at least 132 lbs

You may not qualify if:

  • Clinically significant comorbid disease
  • History of substance abuse
  • Hemoglobin less than 12.0 g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2012

First Posted

January 10, 2013

Study Start

September 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

August 4, 2023

Record last verified: 2023-08