A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease

Phase 1 Completed 4 enrolled Suvankar Majumdar

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the maximum tolerated dose, safety and pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in steady-state sickle cell disease.

Timeline

Start: 2015-01
Primary completion: 2015-12
Completion: 2015-12

Publications

Background Barr FE, Tirona RG, Taylor MB, Rice G, Arnold J, Cunningham G, Smith HA, Campbell A, Canter JA, Christian KG, Drinkwater DC, Scholl F, Kavanaugh-McHugh A, Summar ML. Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension. J Thorac Cardiovasc Surg. 2007 Aug;134(2):319-26. doi: 10.1016/j.jtcvs.2007.02.043.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	L-citrulline	Other / unclassified	20 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	30 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	40 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	50 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	60 mg/kg	Intravenous

A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease

Summary

Timeline

Publications

Drugs

Indications