A Phase 1, Open-Label, Single-dose, Non-randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients

Daiichi Sankyo , Inc.0 sites66 target enrollmentJuly 15, 2016

DrugsLixiana (60 mg Film-coated tablet)Lixiana Lixiana (30 mg film-coated tablet)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Daiichi Sankyo , Inc.
Enrollment: 66
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 15, 2016

End Date

September 16, 2021

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Daiichi Sankyo , Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Able to provide written informed assents (patients, when applicable) and ICFs (signed by parent/legal guardian) prior to participating in the study
•2\. Male or female patients 0 to \< 18 years of age on the day of dosing
•3\. Patients 2 to \< 18 years of age must have a body mass index (BMI) between the 5th and 95th percentile based on the 2000 CDC Growth Charts7 (the maximum number of patients in each dose group that have a BMI between 85th and 95th percentile should not be more than 2 patients). Patients \< 2 years of age must have a body weight between the 5th and 90th percentile based on the 2000 CDC Growth Charts7
•4\. Female patients who have had menarche must test negative for pregnancy at screening and check\-in
•5\. Female patients who have had menarche and are sexually active must use an acceptable contraception method for at least 30 days prior to edoxaban dose
•6\. Patients/Legal guardian(s) must agree to food and drug restrictions during the study
•7\. Patients must agree to abstain from the use of nonsteroidal anti\-inflammatory drugs (such as ibuprofen), and antiplatelet and anticoagulant agents (except for low\-dose aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
•8\. Patients on low\-dose aspirin treatment (1 to 5 mg/kg/day, maximum of 100 mg/day) with an interruption of aspirin 24 hours prior to edoxaban dose and resuming 24 hours after edoxaban dose are permitted to participate in the study per the Investigator’s judgment that this does not place the patients at risk
•9\. Patients must agree to abstain from CYP3A4 inhibitors/inducers and P\-gp inhibitors/inducers for 14 days prior to the edoxaban dose to until after the last PK sample is collected (See Section 5\.2\)
•10\. Patients must agree to abstain from and/or legal guardians must agree not to give the patient cola, tea, coffee, chocolate, and other caffeinated drinks and food from 48 hours before dose administration through check\-out (See Section 5\.3 for a complete list)

Exclusion Criteria

•1\. History (within the last 6 months) of abnormal coagulation tests during screening, as defined by local laboratory reference ranges, which are not explained by anticoagulation therapy
•2\. Stroke where anticoagulant therapy is contraindicated
•3\. Patients with stage 2 hypertension defined as blood pressure confirmed \> 99th percentile \+ 5 mmHg
•4\. Patients with renal function less than 50% of normal for age and size as determined by the National Kidney Disease Education Program version of the Schwartz formula8
•5\. Actively bleeding or has a high risk of bleeding
•6\. Has a currently active gastrointestinal ulceration or a known history of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding including bleeding from hemorrhoids) within the previous 6 months
•7\. Has known diabetic retinopathy
•8\. Has thrombocytopenia at screening (\< 20 × 109/L)
•9\. Has had other unrelated clinically significant illness within 4 weeks prior to Day 1, predose
•10\. Planned invasive procedures during or within 24 hours of study drug administration