Recruiting

Bitter Taste Receptor Blockers

Sponsor:

Monell Chemical Senses Center

Code:

NCT06929455

Conditions

Healthy Adults

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Flavor additives

Study Details

Brief summary:

Many people, particularly small children, must take drugs in liquid form because they cannot swallow pills or capsules. The bad taste of some liquid drugs can keep patients from taking drugs they need for their health. Our main goal in this research study is find ingredients that might make drugs taste better.

Participants in this research study will be healthy adults between the ages of 18 and 60 years old. Participants will taste samples (liquids or gels) containing active pharmaceutical ingredients (substances in medications that produce desired health effects). After tasting each sample participants will spit out the sample and rinse with water (no samples will be swallowed). Active pharmaceutical ingredients of current interest are: 1) tenofovir alafenamide, used to treat HIV infection and hepatitis B, 2) rifampicin, used to treat tuberculosis, 3) rifapentine, used to treat tuberculosis, and 4) levofloxacin, used to treat various bacterial infections). Other active pharmaceutical ingredients may be added as the study goes forward. Participants will be instructed to taste samples both with and without experimental flavor ingredients added and judge how the samples taste. People who volunteer for the study will be instructed to complete many repeated visits to the Monell Center (University City area of Philadelphia) for tasting sessions. Tasting visits will last between 1 and 2 hours.

Conditions

Healthy Adults

Study ID

NCT06929455

Start date

Mar 18, 2025

Status verified date

Apr, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Between the ages of 18 and 60;
  • Generally healthy by self-report;
  • All races/ethnicities, both men and women;
  • Able to provide informed consent;
  • Able to attend repeated visits to Monell for sensory testing;
  • Willing to follow instructions (e.g., refrain from eating or drinking for at least 1 hour before sessions, willing to remain on site for one hour after tasting an API that the participant has never tasted before). -

Exclusion Criteria:

  • Under 18 or over 60;
  • Pregnant, nursing, or plans to become pregnant;
  • Unable to provide consent (including limited ability to understand written and spoken English);
  • Tobacco, vape, marijuana, or tetrahydrocannabinol cartridge users. We will accept people who have used tobacco or marijuana products on occasion, but not regular users;
  • Known drug or food allergies of any kind;
  • Diabetes or other metabolic disorder;
  • Liver issues of any kind, including viral hepatitis;
  • Kidney issues of any kind;
  • Other chronic illness, including cardiovascular, neurological, immune disorders, or any other serious acute or chronic condition
  • Dentures or other major dental implants;
  • Condition affecting the oral cavity, including dry mouth, burning mouth syndrome, active sores or blisters, geographic tongue, or other disorders
  • Current infection or cold, flu, or infection with SARS-CoV-2 within the last four weeks;
  • Unable to taste or smell
  • Daily use, or use within the last four weeks, of either prescription or over-the-counter medications (except for birth control)
  • History of tuberculosis (including latent tuberculosis), positive skin or other tuberculosis test at any time in the past, birth in or residence in a country with high tuberculosis rates, known contact with someone who is tuberculosis positive
  • HIV infection

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: There are no study arms as typically defined in a clinical trial

Various APIs will be presented with and without flavor additives. The list of APIs and additives will be developed as the study progresses, informed by ongoing work using in vitro taste assays. There are no formal, pre-specified study arms as typically defined in a clinical trial.

Interventions

Flavor additives

Various flavors will be added to API samples. The particular APIs and flavor additives to be studied will be determined in part by on-going in work using in vitro taste models (cell systems expressing taste receptor proteins), so there is no full prespecified list.

Primary outcome measure

  • Ratings of flavor intensity [ Time Frame: Through study completion, between about 2 months and 3 years, depending on the number of API-flavor combinations individual participants choose to evaluate ]

Central Contacts and Locations

Central contacts

Paul M Wise, Ph.D.

267-519-4799TasteOfMedicinesStudy@monell.org

Locations

Monell Chemical Senses Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Paul M Wise, Ph.D.

267-519-0400pwise@monell.org

Paul AS Breslin, Ph.D.

267-519-4780breslin@monell.org

More Information

Sponsor

Monell Chemical Senses Center

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Monell Chemical Senses Center on 2025-04-16.