Status:
COMPLETED
Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Healthy
Eligibility:
All Genders
Phase:
PHASE1
Brief 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 pr...
Detailed Description
The immunosuppressant mycophenolate mofetil (MMF) is metabolized by several uridine diphosphate glucuronosyltransferases (UGTs), among which UGT1A9 is the most important enzyme. Two commonly occurring...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Normal healthy volunteers who are in good health as determined by medical history, physical examination, and baseline laboratory tests
- Age 18 - 55
- Both males and females
- Willingness to practice effective contraception during the study and for three months after the administration of MMF for women who are sexually active and have child bearing potential, and for sexually active males who have the potential to father a child. Barrier or non-hormonal methods will be allowed during the study, whereas the use of oral, injectable, or implantable hormones will be prohibited since drug interaction is known to occur between oral contraceptives and mycophenolate mofetil.
- Subjects who are able to understand and sign the informed consent form.
- EXCLUSION CRITERIA:
- Children and adolescents less than 18 years of age
- Individuals who smoke or have excessive alcohol (greater than 1 beer or an equivalent alcoholic beverage per day)
- Pregnant women and nursing mothers
- Subjects with certain underlying diseases which include diabetes, cardiovascular diseases, liver diseases, cancer, and human immunodeficiency virus infection
- Individuals with compromised immune systems
- Subjects who have an active infection
- Individuals with history of biliary tract disease, and biliary or gastrointestinal surgery
- Subjects with persistent diarrhea or other gastrointestinal problems that could impede drug absorption
- Subjects with abnormal liver and kidney functions as determined by medication history and laboratory evaluation (AST and ALT less than or equal to 2 x upper normal limit, total bilirubin less than or equal to 1 mg/dL, serum creatinine less than or equal to 1.2 mg/dL, hemoglobin greater than or equal to 11 g/dL, WBC greater than or equal to 3.5 x 10(9)/L)
- Volunteers on chronic prescribed and over-the-counter medications, and dietary and herbal supplements within 4 weeks of study participation
- Subjects who are taking any medications that could potentially interact with MMF pharmacokinetically and pharmacodynamically such as eccinacea, iron preparations, antacids, bile-resin cholesterol lowering agents, and steroids.
- Volunteers with documented allergy to MMF
- Prior enrollment into a similar study within the past two months and enrollment in another study at the same time
- Subjects who are felt to be unwilling or unable to practice effective contraception methods or comply with protocol specifications
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00128947
Start Date
July 1 2005
End Date
May 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, United States, 20892