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NCT00128947 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT00128947 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 130 participants.
The verdict
NCT00128947, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study Summary
This study will examine how people differ in the way their bodies process and eliminate mycophenolate mofetil (MMF), a drug that is used to treat problems affecting the eye and immune system and to prevent organ rejection in transplant patients. MMF is metabolized by a group of enzymes called UGTs, each of which is made by a different gene. This study will investigate whether people with different UGT genes differ in how well their bodies use and remove MMF. The results may help scientists learn the best way to give MMF to patients. Normal healthy volunteers between 18 and 55 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a blood test for analysis of genes that control and regulate UGTs. Pregnant women and nursing mothers are excluded from the study. Women who are able to have a child and men who can father a child must either abstain from sex or use two reliable forms of birth control during the study and for 3 months after its completion. Participants come to the NIH Clinical Center at 6:30 a.m. on the first day of the study and stay in the outpatient clinic for 12 hours. The next 4 mornings, they return to the Clinical Center for a single blood collection. The procedures for the 5 days are as follows: Day 1 Upon arrival at the Clinical Center a catheter is inserted into the subject's arm vein. At 7:00 AM, the subject takes one dose of MMF by mouth with a glass of water. Small blood samples are collected through the catheter before the MMF dose and again at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours after taking the drug. Heart rate and blood pressure are measured before the blood collection and then every 4 hours. After the last blood sample is collected, the volunteer can return home. Days 2-5 Volunteers come to the Clinical Center at 7:00 AM on study days 2, 3, 4, and 5 for a single blood draw, collected using a needle. Volunteers are contacted by t
Interventions
- DRUG Mycophenolic Acid
- DRUG Mycophenolate 7-O-Phenolic Glucuronide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2005-07 |
| Est. Completion | 2006-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00128947
The ClinicalTrials.gov registry entry for NCT00128947 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mycophenolic Acid is the first listed.
NCT00128947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00128947 about?
NCT00128947 is a clinical study titled "Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers". This study will examine how people differ in the way their bodies process and eliminate mycophenolate mofetil (MMF), a drug that is used to treat problems affecting the eye and immune system and to prevent organ rejection in transplant patients. MMF is metabolized by a group of enzymes called UGTs, ...
What is the current status of trial NCT00128947?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2005-07. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00128947?
The interventions under investigation include: Mycophenolic Acid (DRUG), Mycophenolate 7-O-Phenolic Glucuronide (DRUG).
Who is sponsoring clinical trial NCT00128947?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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