NCT00343954

PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease

Phase 1 Pharmacokinetic and Pharmacodynamic Responses to Oral L-Citrulline in Patients With Sickle Cell Disease

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: Angiogenix · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

To evaluate PK and PD responses to L-citrulline given orally for four weeks to patients with sickle cell disease who are otherwise healthy.

Detailed description

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	L-citrulline tablets, 1000 mg

Timeline

• First posted: 2006-06-23
• Last updated: 2006-06-23

Locations

1 site across 1 country: United States