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

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ClinicalTrials.gov Identifier: NCT00999336
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : September 27, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Portola Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: Betrixaban Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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.
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Betrixaban

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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.

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 Posted: October 21, 2009    Key Record Dates
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
Betrixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants