A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Betrixaban

• Registration Number: NCT02596100
• Lead Sponsor: Portola Pharmaceuticals

Brief Summary

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.

Detailed Description

Serial blood samples will be obtained for PK evaluation.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-21
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet	Betrixaban	80mg immediate release tablet
Capsule	Betrixaban	80mg immediate release capsule

Primary Outcome Measures

Name	Time	Method
Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects	120 hours
Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers	120 hours