Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach
Status:
Completed
Trial end date:
2019-03-31
Target enrollment:
Participant gender:
Summary
Goldenseal is a botanical natural product commonly used to self-treat symptoms of the common
cold and many digestive disorders. Goldenseal products typically contain the isoquinoline
alkaloids berberine, hydrastine, and hydrastinine. These constituents contain a
methylenedioxyphenyl ring, a 'structural alert' that can lead to irreversible inhibition of
drug metabolizing enzymes, particularly the cytochromes P450 (CYPs). Clinical studies
involving healthy volunteers demonstrated that, compared to baseline (absence of goldenseal),
CYP2D6 and CYP3A activities were reduced by 40-60% following treatment with goldenseal.
Compared to the CYPs, the effects of goldenseal products on drug transporters are
understudied, particularly in human subjects. Using a 'cocktail' consisting of 'probe' drug
substrates for CYP3A and various transporters, the effects of goldenseal on the
pharmacokinetics of each probe drug will be examined in healthy volunteers. Results will
provide useful information about the risk of co-consuming goldenseal with additional drugs
that are substrates for transporters.
Phase:
Early Phase 1
Details
Lead Sponsor:
Washington State University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)