A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Portola Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Betrixaban

Study type

Interventional

Funder types

Industry

Identifiers

NCT02596100

15-020

Details and patient eligibility

About

This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.

Full description

Serial blood samples will be obtained for PK evaluation.

Enrollment

52 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.
A healthy man or woman between the ages of 18 and 60
Has no clinically significant findings in medical history, physical examination, EKG and vital signs
Weighs > 45 kg (99 lbs.) and has body mass index (BMI) < 30 kg/m2
Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods
Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods

Exclusion criteria

None of the exclusion criteria may be present for enrollment
Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation
Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug
History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug
History of alcohol abuse (greater than 3 alcoholic beverages per day)
Positive screen for drugs of abuse
Positive serology test for HIV, Hepatitis B or C
Has any allergy or sensitivity to fXa inhibitors