PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease
|ClinicalTrials.gov Identifier: NCT00343954|
Recruitment Status : Unknown
Verified June 2006 by Angiogenix.
Recruitment status was: Not yet recruiting
First Posted : June 23, 2006
Last Update Posted : June 23, 2006
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: L-citrulline tablets, 1000 mg||Phase 1|
Phase 1, single center, open label, multiple-dose study consisting of a screening period followed by four weeks of treatment. At least 12 male and female patients, 10 years of age or older, with sickle cell disease but otherwise healthy, will be enrolled in the study.
PK measurements include plasma concentrations of L-citrulline, L-arginine, L-ornithine, and L-proline following the first dose of orally administered L-citrulline and after four weeks of twice daily administration of the drug.
PD measurements include intercellular and vascular adhesion molecules (ICAM, VCAM, and E-selectin), surrogate markers of sickle cell disease activity, and PAT, a measurement of vascular function.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Pharmacokinetic and Pharmacodynamic Responses to Oral L-Citrulline in Patients With Sickle Cell Disease|
- PK and PD responses to L-citrulline
- Endpoints will be determined as change from baseline
- Assessment of safety and tolerability of L-citrulline,
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343954
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center Health System||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Lakshmanan Krishnamurti, MD 412-692-7192|
|Contact: Sidney Morris, PhD (412) 648-9338|
|Principal Investigator:||Lakshmanam Krishnamurti, MD||Children's Hospital of Pittsburgh, Univ. of Pittsburgh Medical Center|