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Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT02497716
Collaborator
Janssen Research & Development, LLC (Industry)
47
Enrollment
21
Locations
1
Arm
30.6
Actual Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

Condition or Disease Intervention/Treatment Phase
  • Drug: Rivaroxaban (Xarelto, BAY59-7939
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
Actual Study Start Date :
Nov 4, 2015
Actual Primary Completion Date :
May 22, 2018
Actual Study Completion Date :
May 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rivaroxaban

Single arm, open label study

Drug: Rivaroxaban (Xarelto, BAY59-7939
Single dose of reconstituted rivaroxaban granules

Outcome Measures

Primary Outcome Measures

  1. AUC (area under the curve) [4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration]

    Only PK will be tested in central lab

  2. Cmax (maximum observed drug concentration) [4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration]

    Only PK will be tested in central lab

Secondary Outcome Measures

  1. Prothrombin time (PT) [Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration]

  2. Activated partial thromboplastin time (aPTT) [Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration]

  3. Composite of major bleeding and clinically relevant non-major bleeding [From dose administration until follow up call on day 8+3]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Children with an age ≥2 months and weight between 3 and <12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.

  • Gestational age at birth of at least 37 weeks

  • Oral feeding/ nasogastric/ gastric feeding for at least 10 days

  • Normal PT and aPTT within 10 days prior to planned study drug administration

  • Written informed consent provided and, if applicable, child assent provided

Exclusion Criteria:

  • Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy

  • Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake

  • An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2

  • Hepatic disease which is associated either with:

  • coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN), or

  • total bilirubin > 2x ULN with direct bilirubin > 20% of the total.

  • Platelet count < 50 x 10^9/L

  • Hypertension (defined as systolic and/or diastolic blood pressure >95th percentile for age)

  • Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)

  • Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine

  • Inability to cooperate with the study procedures

  • Hypersensitivity to rivaroxaban

  • Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment

  • History of gastrointestinal disease or surgery associated with impaired absorption

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arkansas Children's Hospital Little Rock Arkansas United States 72202
2 Children's Hospital Oakland Oakland California United States 94609
3 Riley Hospital For Children Indianapolis Indiana United States 46202
4 Carolinas Healthcare System Charlotte North Carolina United States 28204
5 Nationwide Children's Hospital Columbus Ohio United States 43205-2696
6 UZ Leuven Gasthuisberg Leuven Belgium 3000
7 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
8 McMaster Children's Hospital Hamilton Ontario Canada L8N 3Z5
9 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
10 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
11 HUS Lastenklinikka HUS Finland 00029
12 Turun yliopistollinen keskussairaala, kantasairaala Turku Finland 20520
13 Hôpital Arnaud de Villeneuve - Montpellier Montpellier France 34059
14 Hopital Necker les enfants malades - Paris Paris France 75015
15 University of Semmelweis/ Semmelweis Egyetem Budapest Hungary 1094
16 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Lombardia Italy 20122
17 A.O.U. Città della Salute e della Scienza di Torino Torino Piemonte Italy 10126
18 A.O. di Padova Padova Veneto Italy 35128
19 Hospital de Sant Joan de Déu Esplugues de LLobregat Barcelona Spain 08950
20 Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona Spain 08035
21 Hospital General Universitario Gregorio Marañón Madrid Spain 28007

Sponsors and Collaborators

  • Bayer
  • Janssen Research & Development, LLC

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02497716
Other Study ID Numbers:
  • 17992
  • 2015-000962-76
First Posted:
Jul 14, 2015
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombosis
Rivaroxaban

Study Results

No Results Posted as of Apr 16, 2019