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

June 21, 2006 updated by: Angiogenix

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, 10 years of age or older on the day of dosing, and generally healthy as determined by medical history, physical examination, and laboratory test values
  2. Diagnosis of sickle cell anemia (Hb SS)
  3. For female of child-bearing potential, a negative serum pregnancy test and using an adequate method of contraception
  4. Has signed and received a copy of the written informed consent form approved by the investigator's Institutional Review Board (IRB), understands the purposes and risks of the study and agrees to follow the restrictions and schedule of procedures as defined by this protocol

Exclusion Criteria:

  1. History of sickle-cell-related pain crisis within two weeks of study
  2. Pregnant or breast feeding
  3. Transfusion within last 90 days
  4. Creatinine >1.5 X upper limit of normal
  5. SGPT > 2 X upper limit of normal
  6. History of allergic reaction to arginine or citrulline product
  7. Requires chronic medication other than study drug that cannot be discontinued during the study period
  8. Unable to take or tolerate oral medications
  9. Unreliable venous access
  10. Noncompliant with regular care
  11. Participation in an investigational drug or medical device study within previous 30 days
  12. In the opinion of the investigator is not a good candidate for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PK and PD responses to L-citrulline
Endpoints will be determined as change from baseline

Secondary Outcome Measures

Outcome Measure
Assessment of safety and tolerability of L-citrulline,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiogenix

Investigators

  • Principal Investigator: Lakshmanam Krishnamurti, MD, Children's Hospital of Pittsburgh, Univ. of Pittsburgh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 21, 2006

First Submitted That Met QC Criteria

June 21, 2006

First Posted (Estimate)

June 23, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2006

Last Update Submitted That Met QC Criteria

June 21, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANGX-3227-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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