Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343954
Status:
UNKNOWN
Last Update Posted:
2006-06-23
First Post:
2006-06-21
Brief Title:
PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease
Sponsor:
Angiogenix
Organization:
Angiogenix
Study Overview
Official Title:
Phase 1 Pharmacokinetic and Pharmacodynamic Responses to Oral L-Citrulline in Patients With Sickle Cell Disease
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None