Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
NCT ID: NCT02303431
Last Updated: 2023-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2014-11-05
2021-09-16
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1a
12 to \< 18 years of age: edoxaban low dose group
Edoxaban low dose
Edoxaban low dose
Cohort 1b
12 to \< 18 years of age: edoxaban high dose group
Edoxaban high dose
Edoxaban high dose
Cohort 2a
6 to \< 12 years of age: edoxaban low dose group
Edoxaban low dose
Edoxaban low dose
Cohort 2b
6 to \< 12 years of age: edoxaban high dose group
Edoxaban high dose
Edoxaban high dose
Cohort 3a
2 to \< 6 years of age: edoxaban low dose group
Edoxaban low dose
Edoxaban low dose
Cohort 3b
2 to \< 6 years of age: edoxaban high dose group
Edoxaban high dose
Edoxaban high dose
Cohort 4a
6 months to \<2 years of age: edoxaban low dose group
Edoxaban low dose
Edoxaban low dose
Cohort 4b
6 months to \<2 years of age: edoxaban high dose group
Edoxaban high dose
Edoxaban high dose
Cohort 5a
0 to 6 months of age: edoxaban low dose group
Edoxaban low dose
Edoxaban low dose
Cohort 5b
0 to 6 months: edoxaban high dose group
Edoxaban high dose
Edoxaban high dose
Interventions
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Edoxaban low dose
Edoxaban low dose
Edoxaban high dose
Edoxaban high dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Years
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
University of Colorado Denver
Denver, Colorado, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States
University of Louisville ; Kosair Charities Pediatric Clincial Research Unit
Louisville, Kentucky, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
St. Jude Children's Research Hospital, Inc.
Memphis, Tennessee, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
McMaster Children's Hospital
Hamilton, Ontario, Canada
Childrens Hospital of Eastern Ontario
Ottawa, , Canada
Hopital Arnaud de Villeneuve
Montpellier, , France
CHU Bordeaux - Hopital Haut-Leveque
Pessac, , France
Nirmal Hospital Pvt. Ltd
Gujrāt, , India
Institute of Child Health
Kolkata, , India
Christian Medical College and Hospital
Ludhiāna, , India
Istituto Giannina Gaslini - UOSD Emostasi e Trombosi
Genova, , Italy
A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova
Padua, , Italy
Bambino Gesu Hospital
Rome, , Italy
Hotel Dieu De France
Beirut, , Lebanon
Hammoud Hospital University Medical Center
Saida, , Lebanon
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Araba
Vitoria-Gasteiz, , Spain
Ege University Medical Faculty - Department of Pediatric Hematology
Izmir, , Turkey (Türkiye)
Leeds General Infirmary
Leeds, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Guy's and St Thomas Hospital NHS Trust
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-005732-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DU176b-A-U157
Identifier Type: -
Identifier Source: org_study_id
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