Healthy AdultsNCT06929455
Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines
A study testing Flavor additives in people with Healthy Adults, run by Monell Chemical Senses Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Flavor additives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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). -
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
Paul M Wise, Ph.D., 267-519-0400, pwise@monell.org
Paul AS Breslin, Ph.D., 267-519-4780, breslin@monell.org
About this study
Official title: Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines: Trained Human Sensory Panels
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
- Being tested
- Flavor additives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavor additivesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| There are no study arms as typically defined in a clinical trial | Other | 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. Receives: Other: Flavor additives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of flavor intensity
Ratings of oral sensation (e.g., bitterness, sourness, astringency, etc.) made using the general Labeled Magnitude Scale. Values range from 0 (no sensation) to 100 (strongest imaginable sensation)
Measured: Through study completion, between about 2 months and 3 years, depending on the number of API-flavor combinations individual participants choose to evaluate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start18 Mar 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There are no formal arms. Some samples will contain pharmaceutical ingredients without added flavors (control), and some samples will contain both pharmaceutical ingredients and flavor additives (experimental condition to determine if added flavors ingredients improve the flavor of the samples).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Collaborators
- NIAID, Division of AIDS (contract funder), Advanced Biosciences Laboratories (ABL; primary contract holder)
- Responsible party
- Sponsor
- Investigators
- Paul M Wise, Ph.D., Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929455
- Sponsor's protocol ID
- 75N93024F00002
- Other IDs
- AI 75N93023D00001
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with qualified researchers upon request, and may be made available in managed repositories as allowed by funder and journal policy.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines: Trained Human Sensory Panels
- ClinicalTrials.gov ID
- NCT06929455
- Acronym / sponsor ID
- 75N93024F00002
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Collaborators
- NIAID, Division of AIDS (contract funder), Advanced Biosciences Laboratories (ABL; primary contract holder)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are no formal arms. Some samples will contain pharmaceutical ingredients without added flavors (control), and some samples will contain both pharmaceutical ingredients and flavor additives (experimental condition to determine if added flavors ingredients improve the flavor of the samples).
| Arm | Type | Receives |
|---|---|---|
| There are no study arms as typically defined in a clinical trial | Other | Other: Flavor additivesVarious 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavor additivesVarious 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. | Other | There are no study arms as typically defined in a clinical trial |
Primary outcome
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
Ratings of oral sensation (e.g., bitterness, sourness, astringency, etc.) made using the general Labeled Magnitude Scale. Values range from 0 (no sensation) to 100 (strongest imaginable sensation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with qualified researchers upon request, and may be made available in managed repositories as allowed by funder and journal policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul M Wise, Ph.D. principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavor additives in people with Healthy Adults, run by Monell Chemical Senses Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul M Wise, Ph.D. (267-519-4799, TasteOfMedicinesStudy@monell.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.