Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

  • STATUS
    Recruiting
  • End date
    Sep 4, 2021
  • participants needed
    60
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 4 April 2021
aspirin
anticoagulants
anticoagulant therapy
edoxaban

Summary

This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

Description

Phase 1, open-label, multiple-center study in pediatric patients from 0 to < 18 years of age. Patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the 60 mg (high dose) exposure in adults. Exact doses will be selected during the study on the basis of PK modeling of emerging data. If unanticipated exposures are observed, the target doses may be modified to best match expected exposure response relationships observed in adults.

Enrollment in the study will start with the low dose, highest age group (adolescents) and will continue from low to high dose in each age group and from higher to lower age groups. Enrollment in the next dose/age cohort will begin after 50% of the subjects have completed the previous dose/age cohort.

Age cohorts and dose groups: (6 participants each in low and high dose groups, for a total of 12 participants per age cohort)

  • 12 to < 18 years of age
  • 6 to <12 years of age
  • 2 to <6 years of age
  • 6 months to <2 years of age
  • 0 to <6 months of age

Details
Condition Venous Thrombosis, Venous Thromboembolism, Thromboembolism, Thrombosis, Blood Clots, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis
Treatment Edoxaban low dose, Edoxaban high dose
Clinical Study IdentifierNCT02303431
SponsorDaiichi Sankyo, Inc.
Last Modified on4 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thrombosis or Venous Thromboembolism or Blood Clots or Thromboembolism or Deep Vein Thrombosis or Thrombosis?
Do you have any of these conditions: Venous Thromboembolism or Deep Vein Thrombosis or deep venous thrombosis of lower extremity or deep venous thrombosis or Thrombosis or Venous Thrombos...?
Do you have any of these conditions: Venous Thrombosis or Thromboembolism or deep venous thrombosis of lower extremity or Thrombosis or Blood Clots or Venous Thromboembolism or deep venou...?
Do you have any of these conditions: Venous Thrombosis or Venous Thromboembolism or Deep Vein Thrombosis or Thrombosis or Thromboembolism or deep venous thrombosis of lower extremity or B...?
Do you have any of these conditions: Thrombosis or Deep Vein Thrombosis or Venous Thrombosis or deep venous thrombosis of lower extremity or deep venous thrombosis or Thromboembolism or V...?
Do you have any of these conditions: Thrombosis or deep venous thrombosis of lower extremity or Thromboembolism or Venous Thromboembolism or Venous Thrombosis or Deep Vein Thrombosis or B...?
Do you have any of these conditions: Venous Thromboembolism or Venous Thrombosis or Deep Vein Thrombosis or deep venous thrombosis or Thromboembolism or Thrombosis or Blood Clots or deep ...?
Do you have any of these conditions: Venous Thrombosis or deep venous thrombosis or Blood Clots or deep venous thrombosis of lower extremity or Venous Thromboembolism or Deep Vein Thrombo...?
Do you have any of these conditions: deep venous thrombosis or Thrombosis or deep venous thrombosis of lower extremity or Venous Thromboembolism or Deep Vein Thrombosis or Venous Thrombos...?
Do you have any of these conditions: deep venous thrombosis of lower extremity or Venous Thrombosis or deep venous thrombosis or Blood Clots or Thrombosis or Venous Thromboembolism or Dee...?
Is a pediatric subject requiring anticoagulant therapy
Will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
Will follow food and concomitant medication restrictions

Exclusion Criteria

Any major or clinically relevant unexplained bleeding during prior anticoagulant therapy
History of abnormal bleeding or coagulation within last 6 months prior to study drug administration
Renal function with glomerular filtration rate (GFR) less than 50% of normal for age and size
Malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)
Hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk, alanine transaminase (ALT) > 5 times the upper limit of normal (ULN) or total bilirubin > 2 times the ULN with direct bilirubin > 20% of the total
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