Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Betrixaban · 1 trial · 1 indication
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).
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).
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.
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).
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.
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.
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 (%).
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of thrombin generation for all participants.
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).
| Arm | Type | Description |
|---|---|---|
| Group H | ACTIVE_COMPARATOR | Healthy subjects matched to the renal impairment groups |
| Group A | EXPERIMENTAL | Patients with mild renal impairment |
| Group B | EXPERIMENTAL | Patients with moderate renal impairment |
| Group C | EXPERIMENTAL | Patients with severe renal impairment |
| Name | Type | Description |
|---|---|---|
| Betrixaban | DRUG | 80 mg betrixaban qd for 8 days |
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 ...
Betrixaban is an investigational small molecule being studied for use in patients with renal impairment. A completed Phase 1 trial evaluated its pharmacokinetics, pharmacodynamics, and tolerability in patients with mild, moderate, and severe renal impairment. The study enrolled 32 participants in Germany.
Betrixaban is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored a Phase 1 clinical trial of the drug in patients with renal impairment.
Betrixaban is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
Betrixaban has one completed clinical trial, NCT00999336, titled "A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment." This Phase 1 study enrolled 32 participants and was conducted in Germany.
No alternative names for Betrixaban have been disclosed. It is referred to solely by its generic name, Betrixaban, in clinical trial records and development documentation.