A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Betrixaban

Detailed Description

Serial blood samples will be obtained for PK evaluation.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tablet; 80mg immediate release tablet	Drug: Betrixaban
Experimental: Capsule; 80mg immediate release capsule	Drug: Betrixaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Portola Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimated): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Bioequivalence
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Betrixaban
• Other Study ID Numbers: 15-020