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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:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00999336
First received: October 20, 2009
Last updated: September 23, 2010
Last verified: September 2010
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetics of betrixaban [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999336

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

No publications provided

Responsible Party: Eduard Gorina, MD/Senior Director, Clinical Development, Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00999336     History of Changes
Other Study ID Numbers: 08-016
Study First Received: October 20, 2009
Last Updated: September 23, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014