An Assessment of Milk Thistle Pharmacokinetics and Drug Interactions

NCT00200798 | Completed DMC

• 1 other identifier: R21AT002817-01
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Milk Thistle; Silymarin; pharmacokinetics; drug interactions; Normal volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Normal healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

Medical University of South Carolina, GCRC

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma \& urine

Study Officials

• John S. Markowitz, Pharm.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Thomas W Uhde, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 17, 2018

Record last verified: 2018-04

Locations

US (1)