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

Primary outcomes

1. Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8

   Time frame: Predose up to 168 hours postdose

   Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.

   Results were reported in nanogram multiplied by hour per milliliter (ng*h/mL).

2. Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8

   Time frame: Predose, up to 168 hours postdose

   Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.

   Results were reported in nanogram per milliliter (ng/mL).

3. Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8

   Time frame: Predose, up to 168 hours postdose

   Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.

   Harmonic mean and Jackknife standard deviation was used to report this outcome and results were reported in hour.

4. Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8

   Time frame: Predose, up to 168 hours postdose

   Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.

   Results were reported in milliliter per minute (mL/min).

5. Volume Of Distribution During The Terminal Phase (Vz/F) Following Administration Of Oral Doses Of Betrixaban On Day 8

   Time frame: Predose, up to 168 hours postdose

   Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.

   Results were reported in liter.

6. Percentage Of Dose Excreted In Urine From 0-24 (fe0-24) Postdose Of Oral Doses Of Betrixaban On Day 8

   Time frame: Predose, up to 24 hours postdose

   Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.

   Results were reported in percentage.

7. Percentage Of Betrixaban Bound To Plasma Proteins On Day 8

   Time frame: 4 hours Postdose at Day 8

   Blood samples were collected for measurement of plasma protein binding for betrixaban for all participants. Results of protein binding assays were summarized by sample time and eGFR group. Results were reported in percent (%).

8. Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8

   Time frame: Day 1: predose; Day 8: 2, 3, 4, 8, 24, and 48 hours postdose

   Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of thrombin generation for all participants.

9. Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8

   Time frame: Day 8: 2, 3, 4, 8, 24, and 48 hours postdose

   Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of anti-fXa activity at baseline and steady state for all participants.

   Results were reported in international units per milliliter (IU/mL).