A Human Phase I Absolute Bioavailability Study of PRT0540... | NCT01765868

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

NCT01765868

Sponsor

Portola Pharmaceuticals

Status

Completed

Last Update Posted

Aug 8, 2023Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

Betrixaban

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Dec 28, 2012

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2023

Last Update Posted Date

Aug 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm Oral and IV Betrixaban	Experimental		Drug: Betrixaban

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betrixaban	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	Single Arm Oral and IV Betrixaban

Measure	Description	Time Frame
Percent of orally absorbed dose		over 72 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C543086	betrixaban

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided