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NCT03772262 · ClinicalTrials.gov registry record · Early Phase 1
Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach
A Early Phase 1 study, sponsored by Washington State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT03772262: Completed Early Phase 1 study, sponsored by Washington State University.
NCT03772262 is a Early Phase 1 study that has completed, run by Washington State University. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03772262, a Early Phase 1 study, has completed, sponsored by Washington State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of goldenseal
Interventions
- DRUG Metformin
- DRUG Furosemide
- DRUG Midazolam oral solution
- DIETARY_SUPPLEMENT goldenseal
- DRUG Rosuvastatin Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2019-03-31 |
| Phase | Early Phase 1 |
What the finished NCT03772262 record still lists
NCT03772262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT03772262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03772262 about?
NCT03772262 is a clinical study titled "Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach". 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 'structu...
What is the current status of trial NCT03772262?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2018-04-05. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT03772262?
The interventions under investigation include: Metformin (DRUG), Furosemide (DRUG), Midazolam oral solution (DRUG), goldenseal (DIETARY_SUPPLEMENT), Rosuvastatin Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03772262?
This trial is sponsored by Washington State University, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03772262's enrollment target sits among peer trials
16 1369th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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