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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:
ClinicalTrials.gov Identifier:
NCT00999336
First Posted: October 21, 2009
Last Update Posted: September 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Portola Pharmaceuticals
  Purpose
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.

Condition Intervention Phase
Renal Impairment Drug: Betrixaban Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetics of betrixaban [ Time Frame: 8 days ]

Secondary Outcome Measures:
  • Safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 17 days ]
  • Measures of anti-coagulation [ Time Frame: 3 days ]

Estimated Enrollment: 32
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group H
Healthy subjects matched to the renal impairment groups
Drug: Betrixaban
80 mg betrixaban qd for 8 days
Experimental: Group A
Patients with mild renal impairment
Drug: Betrixaban
80 mg betrixaban qd for 8 days
Experimental: Group B
Patients with moderate renal impairment
Drug: Betrixaban
80 mg betrixaban qd for 8 days
Experimental: Group C
Patients with severe renal impairment
Drug: Betrixaban
80 mg betrixaban qd for 8 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999336


Locations
Germany
APEX GmbH
Munich, Germany
Sponsors and Collaborators
Portola Pharmaceuticals
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Eduard Gorina, MD/Senior Director, Clinical Development, Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00999336     History of Changes
Other Study ID Numbers: 08-016
First Submitted: October 20, 2009
First Posted: October 21, 2009
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by Portola Pharmaceuticals:
Betrixaban
Renal impairment
Healthy
Kidney dysfunction

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases