A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

Portola Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00999336

First received: October 20, 2009

Last updated: September 23, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 20, 2009
Last Updated Date	September 23, 2010
Start Date ^ICMJE	July 2009
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 20, 2009)	Pharmacokinetics of betrixaban [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00999336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 20, 2009)	Safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 17 days ] [ Designated as safety issue: No ] Measures of anti-coagulation [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Official Title ^ICMJE	Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.
Brief Summary	The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Renal Impairment
Intervention ^ICMJE	Drug: Betrixaban 80 mg betrixaban qd for 8 days
Study Arm (s)	Active Comparator: Group H Healthy subjects matched to the renal impairment groups Intervention: Drug: Betrixaban Experimental: Group A Patients with mild renal impairment Intervention: Drug: Betrixaban Experimental: Group B Patients with moderate renal impairment Intervention: Drug: Betrixaban Experimental: Group C Patients with severe renal impairment Intervention: Drug: Betrixaban
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	32
Completion Date	February 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Able to understand and sign the written informed consent. Subjects should have either normal renal function or have stable renal disease Exclusion Criteria: Subjects require dialysis Evidence of active bleeding or bleeding disorder Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00999336
Other Study ID Numbers ^ICMJE	08-016
Has Data Monitoring Committee	No
Responsible Party	Eduard Gorina, MD/Senior Director, Clinical Development, Portola Pharmaceuticals
Study Sponsor ^ICMJE	Portola Pharmaceuticals
Collaborators ^ICMJE	Merck
Investigators ^ICMJE	Not Provided
Information Provided By	Portola Pharmaceuticals
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top