Phase 1
Completed N=32
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Source: ClinicalTrials.gov NCT00999336 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Aug 2023
Primary outcomePrimary: Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8 — 437; 807; 1033; 995 ng*h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8 |
437; 807; 1033; 995 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8 |
44.0; 84.3; 108; 104 | — |
| PRIMARY Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8 |
54.4; 56.0; 60.7; 55.6 | — |
| PRIMARY Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8 |
4042; 1815; 1887; 1715 | — |
| PRIMARY Volume Of Distribution During The Terminal Phase (Vz/F) Following Administration Of Oral Doses Of Betrixaban On Day 8 |
20128; 8795; 9518; 9562 | — |
| PRIMARY Percentage Of Dose Excreted In Urine From 0-24 (fe0-24) Postdose Of Oral Doses Of Betrixaban On Day 8 |
5.07; 5.40; 5.04; 2.72 | — |
| PRIMARY Percentage Of Betrixaban Bound To Plasma Proteins On Day 8 |
58.6; 61.3; 59.4; 59.9 | — |
| PRIMARY Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8 |
12494; 14168; 11833; 10021; 6359; 4484 | — |
| PRIMARY Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8 |
0.18; 0.36; 0.48; 0.44; 0.27; 0.40 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00999336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.