An Assessment of Milk Thistle Pharmacokinetics and Drug Interactions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00200798
First received: September 13, 2005
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

There is accumulating evidence from various sources that extracts from the milk thistle plant can be useful in the treatment of a variety of liver ailments as well as other disorders. This investigation will essentially be composed of two individual normal volunteer studies of milk thistle. The first study will assess the rate and extent of absorption of components of a standardized botanical extract obtained from the milk thistle plant. This first study is termed a bioavailability study. This investigation will take approximately 8 weeks and involve 10 clinic visits. Secondly, a drug interaction study will be performed. This is an assessment study of the potential for this botanical extract to interact with other prescription or over-the-counter medications. This study is also expected to take approximately 8 weeks but will involve 18 clinic visits. In both studies all subjects will receive the same milk thistle supplement and no placebo will be administered.


Condition Phase
Healthy
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pharmacokinetics and Drug Interactions With Milk Thistle

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Biospecimen Retention:   Samples Without DNA

plasma & urine


Estimated Enrollment: 32
Study Start Date: May 2006
Estimated Study Completion Date: August 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal healthy volunteers

Criteria

Inclusion Criteria:

  • Age range: 18-45 years old
  • Race or ethnicity: no restrictions
  • Health status: subjects must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during the screening medical history, physical exam, and laboratory evaluations.
  • Must have no history of significant psychiatric illness or substance use.
  • Written Informed Consent as well as Health Insurance Portability and Accountability Act (HIPAA) authorization forms must be signed by the eligible subject prior to the initiation of any study procedures.

Exclusion Criteria:

Any of the following conditions are cause for exclusion and/or discontinuation from the study:

  • The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion.
  • A positive urine pregnancy test
  • The use of oral contraceptives
  • The lack of use of acceptable barrier methods of birth control unless abstinent
  • The use of any concomitant medication including herbal medications, over-the-counter (OTC) supplements, or a history of hypersensitivity to DM, ALPZ, TOL, or caffeine (CAF) and any history of sensitivity to milk thistle or any of its components.
  • Subjects genotyped as poor metabolizers of CYP2D6 at screening
  • Active smoking or use of CAF containing beverage (coffee, certain colas) for one week prior and during the study period due to known effects on CYP1A2 activity.
  • Subjects expressing inability to conform to dietary restrictions required for the study
  • The use of any illicit drugs or habitual consumption of large quantities of ethanol (> 3 drinks/day)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200798

Contacts
Contact: John S. Markowitz, Pharm.D. 843-792-0172 markowij@musc.edu
Contact: Jennifer L. Donovan, Ph.D. 843-792-5589 donovanj@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina, GCRC Recruiting
Charleston, South Carolina, United States, 29425
Sub-Investigator: Jennifer L. Donovan, Ph.D.         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: John S. Markowitz, Pharm.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: John S. Markowitz, Pharm.D., MUSC
ClinicalTrials.gov Identifier: NCT00200798     History of Changes
Other Study ID Numbers: R21 AT002817-01, R21AT002817-01
Study First Received: September 13, 2005
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
Milk Thistle
Silymarin
pharmacokinetics
drug interactions
Normal volunteers

ClinicalTrials.gov processed this record on July 29, 2014