Protocol 16-021 – Pediatric PK
Research type
Research Study
Full title
A phase 1, open-label, single dose, non-randomized study to evaluate pharmacokinetics, pharmacodynamics, and safety of Betrixaban in pediatric patients.
IRAS ID
250757
Contact name
Jayanthi Alamelu
Contact email
Sponsor organisation
Portola Pharmaceuticals, Inc.
Eudract number
2018-002562-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 2 days
Research summary
Betrixaban is a type of blood thinner that is taken by mouth. When a patient takes this drug, it may help to reduce the chance of having a blood clot. The purpose of this study is to find out how much betrixaban gets into the blood stream when a single, oral dose is taken by children, and teenagers up to 18 years of age, and whether it is safe for them to take a single dose of betrixaban. \nApproximately 33 patients from the age of 2 to 17 years old are expected to participate in this study which will be conducted at several sites. The current study will be conducted in two parts. The first part of the study will involve adolescents (12 to < 16 years of age) and young adults (16-17 years of age), and then proceeding to include progressively younger age groups (2 to < 12), as an oral pediatric formulation becomes available.\nPatients will receive one dose of betrixaban by mouth. This is an “open-label” study. An open-label study is a type of clinical trial in which both the researchers and participants know which treatment is being given. In first part of the study, two doses of betrixaban will be used - 40 mg and 80 mg depending on the time of enrollment in the study. \nParticipants are expected to be in the study for a total of approximately 5 weeks. This will consist of up to 30 day screening period, dosing (study drug intake) and 7 day follow-up period.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0129
Date of REC Opinion
29 Jul 2019
REC opinion
Further Information Favourable Opinion