Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients

Summary

L-glutamine has been approved in the US to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. The purpose of this single-center, open-label, phase 4 study is to evaluate the pharmacokinetic characteristics and safety of L-glutamine in patients with SCD.

Timeline

Start

2021-01-04

Primary completion

2021-06-30

Completion

2021-06-30

Publications

• Sadaf A, Dong M, Pfeiffer A, Latham T, Kalfa T, Vinks AA, Ware RE, Quinn CT. A Population Pharmacokinetic Analysis of L-Glutamine Exposure in Patients with Sickle Cell Disease: Evaluation of Dose and Food Effects. Clin Pharmacokinet. 2024 Mar;63(3):357-365. doi: 10.1007/s40262-024-01349-4. Epub 2024 Feb 24.

Drugs

Indications