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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

October 20, 2009
September 23, 2010
July 2009
February 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of betrixaban [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999336 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Impairment
Drug: Betrixaban
80 mg betrixaban qd for 8 days
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00999336
08-016
No
Eduard Gorina, MD/Senior Director, Clinical Development, Portola Pharmaceuticals
Portola Pharmaceuticals
Merck Sharp & Dohme Corp.
Not Provided
Portola Pharmaceuticals
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP