NCT02596100

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

October 21, 2015

Last Update Submit

August 7, 2023

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Tablet

EXPERIMENTAL

80mg immediate release tablet

Drug: Betrixaban

Capsule

EXPERIMENTAL

80mg immediate release capsule

Drug: Betrixaban

Interventions

BetrixabanDRUG
CapsuleTablet

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

betrixaban

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

November 4, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 8, 2023

Record last verified: 2023-08