Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Phase 1 Completed 49 enrolled Bristol-Myers Squibb Pfizer · collab

Non-randomizedParallel-groupOpen-labelOther

Summary

CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis

Timeline

Start: 2013-01-10
Primary completion: 2020-06-30
Completion: 2020-06-30

Publications

Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B. Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder. CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apixaban	Small molecule	0.1 mg	Oral
Subject	Apixaban	Small molecule	0.4 mg/ml	Oral
Subject	Apixaban	Small molecule	1.08 mg/m2	Oral
Subject	Apixaban	Small molecule	2.19 mg/m2	Oral

Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Summary

Timeline

Publications

Drugs

Indications