Evaluating the Pharmacokinetics of Oregano and Potential Oregano-drug Interactions Using a Drug Cocktail Approach

NCT06693960 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 20296U54AT008909
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to determine how the supplement oregano affects how the body metabolizes pharmaceutical drugs.

Conditions

Interaction

Keywords

pharmacokinetics; drug interaction; natural products; oregano; cytochrome P450; cocktail

Outcome Measures

Primary Outcomes (1)

• Midazolam Area under the plasma concentration vs. time curve (AUC) ratio

  Ratio of the area under the plasma concentration vs. time curve of midazolam in the presence to absence of oregano.

  0-24 hours

Secondary Outcomes (14)

• Caffeine AUC ratio

  0-24 hours

• Caffeine maximum plasma concentration (Cmax) ratio

  0-24 hours

• Caffeine half-life ratio

  0-24 hours

• Dextromethorphan AUC ratio

  0-24 hours

• Dextromethorphan Cmax ratio

  0-24 hours

Study Arms (4)

Arm 1: oregano alone

EXPERIMENTAL

6 participants will be administered 180 mg of a well-characterized oregano product. Blood will be drawn via an indwelling venous catheter immediately before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration of oregano. Urine will be collected in multiple jugs for 24 hours.

Dietary Supplement: Oregano

Arm 2: drug cocktail alone

EXPERIMENTAL

16 participants, which may or may not include any number of the original 6 from Arm 1, will be administered an oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg). Blood and urine will be collected in the same manner described in Arm 1.

Drug: Drug cocktail

Arm 3: acute oregano + cocktail

EXPERIMENTAL

The same 16 participants will be administered the oregano product and the drug cocktail. Blood and urine will be collected in the same manner described in Arm 1.

Dietary Supplement: Oregano; Drug: Drug cocktail

Arm 4: chronic oregano + cocktail

EXPERIMENTAL

The same 16 participants will self-administer the oregano product at home for 5 consecutive days. On day 6, participants will return to the study setting, where the procedure described in Arm 3 will be repeated.

Dietary Supplement: Oregano; Drug: Drug cocktail

Interventions

Oregano DIETARY_SUPPLEMENT

Oil of oregano administered as a softgel (180 mg).

Arm 1: oregano alone; Arm 3: acute oregano + cocktail; Arm 4: chronic oregano + cocktail

Drug cocktail DRUG

Oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg).

Arm 2: drug cocktail alone; Arm 3: acute oregano + cocktail; Arm 4: chronic oregano + cocktail

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-64 years old and healthy
• Not taking any medications (prescription and non-prescription) or dietary/herbal supplements that can interfere with study drug pharmacokinetics
• Willing to abstain from consuming dietary/herbal supplements and citrus juices for several weeks
• Willing to abstain from cannabis/marijuana, hemp, and THC- and CBD-containing products for several weeks
• Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and the morning of the first day of each study arm
• Willing to abstain from consuming any alcoholic beverages for at least 1 day prior to any study day and during the study day
• Willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms). Specifically, regardless of the use hormonal-based birth control, a non-hormonal method should be used for the duration of the study and for three weeks following cessation of participation.
• Willing to abstain from consuming oregano (as a food additive or otherwise) for the duration of the study
• Geographically located within a 40-mile radius of Spokane and have the time to participate

You may not qualify if:

• Under 18 or over 64 years old
• Taking medications or dietary/herbal supplements that can interfere with study drug pharmacokinetics
• Have a major illness
• Taking medication/supplements for a mineral deficiency
• History of intolerance or allergy to oregano or any of the cocktail drugs (caffeine, dextromethorphan, losartan, midazolam, and omeprazole)
• Use of cannabis/marijuana, hemp, and CBD- and/or THC-containing products within the last month
• Currently using drugs or illicit substances for recreational purposes
• Pregnant or nursing
• Geographically located outside the 40-mile radius of Spokane and do not have the time to participate
• Cannot read and speak English

Sponsors & Collaborators

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

Study Sites (1)

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, 99202, United States

RECRUITING

Central Study Contacts

Mary F Paine, RPh, PhD

CONTACT

509-358-7759; mary.paine@wsu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: September 26, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)