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



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:2/20/2019
Start Date:April 13, 2016
End Date:December 31, 2019

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

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.

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

Inclusion Criteria:

- 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
We found this trial at
15
sites
725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Phone: 650-497-8953
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Phone: 904-697-3789
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Phone: 901-595-4753
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-4040
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Boston, Massachusetts 02115
Phone: 617-919-3242
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-1549
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Denver, Colorado 80291
Phone: 303-724-0365
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Durham, North Carolina 27710
Phone: 919-684-5350
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Hamilton, Ontario
Phone: 905-599-3326
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Indianapolis, Indiana 46260
Phone: 317-871-0000
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Indianapolis, IN
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Los Angeles, California 90095
Phone: 310-825-0867
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210 East Gray Street
Louisville, Kentucky 40202
Phone: 502-629-5830
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Phone: 414-266-1777
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Providence, Rhode Island 02903
Phone: 401-444-5171
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