Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease

NCT00842088 ↗

Phase 1/2 Completed 24 enrolled HemaQuest Pharmaceuticals Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability of HQK-1001 administered for a total of 12 weeks (with one dosing break) in subjects with sickle cell disease.

Timeline

Start: 2009-03
Primary completion: 2010-07
Completion: —

Publications

Kutlar A, Ataga K, Reid M, Vichinsky EP, Neumayr L, Blair-Britt L, Labotka R, Glass J, Keefer JR, Wargin WA, Berenson R, Perrine SP. A phase 1/2 trial of HQK-1001, an oral fetal globin inducer, in sickle cell disease. Am J Hematol. 2012 Nov;87(11):1017-21. doi: 10.1002/ajh.23306. Epub 2012 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium dimethylbutyrate	Unknown	10 mg/kg	Oral
Subject	sodium dimethylbutyrate	Unknown	20 mg/kg	Oral
Subject	sodium dimethylbutyrate	Unknown	30 mg/kg	Oral

Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease

Summary

Timeline

Publications

Drugs

Indications