Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI

Summary

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS contrast-enhanced MRI (CNS cohort).

Timeline

Start

2018-11-06

Primary completion

2019-12-18

Completion

2020-08-10

Publications

• Jurkiewicz E, Tsvetkova S, Grinberg A, Pasquiers B. Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. Invest Radiol. 2022 Aug 1;57(8):510-516. doi: 10.1097/RLI.0000000000000865. Epub 2022 Mar 2.

Drugs

Indications