Bitter Taste Receptor Blockers for Improving Pediatric Medicine Palatability

Overseen By Paul M Wise, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Monell Chemical Senses Center

Must not be taking: Prescription medications

Disqualifiers: Pregnancy, Tobacco, Diabetes, Liver issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover new methods to improve the taste of liquid medicines, particularly for children who cannot swallow pills. Participants will taste medicine samples, both with and without special flavor additives (bitter taste receptor blockers), and provide feedback on the taste. The trial involves healthy adults aged 18-60 who can attend multiple tasting sessions in Philadelphia. Volunteers should not have chronic illnesses or allergies and must not use tobacco or marijuana regularly. As an unphased trial, this study offers a unique opportunity to contribute to enhancing medicine palatability for children.

Will I have to stop taking my current medications?

Yes, participants must not have used any prescription or over-the-counter medications daily or within the last four weeks, except for birth control.

What prior data suggests that these flavor additives are safe for human tasting?

Research has shown that taste blockers and flavor additives can improve the taste of bitter medicines. These additives are being tested to enhance the palatability of medicines, particularly for children who find some drugs unpleasant.

In this study, participants will taste medicines such as tenofovir alafenamide, rifampicin, rifapentine, and levofloxacin, which treat HIV, hepatitis B, tuberculosis, and bacterial infections. Participants will taste and then spit out the samples, reducing any health risks.

While few studies have examined the safety of these flavor additives in humans, they are generally considered safe in food. Additionally, since participants will not swallow the substances, safety concerns are further minimized. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using flavor additives to improve the taste of pediatric medicines because they offer a novel way to make medications more palatable for kids without changing the medicine itself. Unlike traditional methods, which may involve masking flavors with sugar or syrups, these additives specifically target and block bitter taste receptors. This innovative approach could lead to better adherence to medication regimens among children, as it directly addresses the unpleasant taste that often discourages them from taking their medicine. By improving the taste, this method has the potential to make taking medicine a less stressful experience for both kids and parents.

What evidence suggests that these flavor additives could improve the taste of pediatric medicines?

Research has shown that certain ingredients, such as some sodium salts, can improve the taste of bitter medicines for children. Studies have found that when medicines taste better, children are more likely to take them as directed, which leads to better health outcomes due to increased treatment completion. Many studies highlight that bad-tasting medicines often cause children to avoid taking them. This trial uses flavor additives to make medication more pleasant to taste. ^{1 3 6 7 8}

Who Is on the Research Team?

Paul M Wise, Ph.D.

Principal Investigator

Monell Chemical Senses Center

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 60 who are interested in helping improve the taste of pediatric medicines. Participants will be tasting, but not swallowing, various liquid or gel samples containing active ingredients used in medications like those for HIV and tuberculosis.

Inclusion Criteria

Able to provide informed consent

My gender or race does not exclude me from this trial.

I can go to Monell for multiple sensory tests.

Exclusion Criteria

I have diabetes or another metabolic disorder.

Pregnant, nursing, or plans to become pregnant

Dentures or other major dental implants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tasting Sessions

Participants taste samples containing active pharmaceutical ingredients with and without experimental flavor ingredients and judge how the samples taste.

2 months to 3 years

Many repeated visits to the Monell Center, each lasting 1-2 hours

Follow-up

Participants are monitored for any adverse reactions or changes in taste perception after tasting sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flavor additives

Trial Overview The study is testing flavor additives that could block bitter taste receptors, aiming to make liquid drugs more palatable for children. Adults will sample these potential additives with different medications during visits to the Monell Center.

How Is the Trial Designed?

Group I: There are no study arms as typically defined in a clinical trial Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Monell Chemical Senses Center

Lead Sponsor

Trials

22

Recruited

2,200+

NIAID, Division of AIDS (contract funder)

Collaborator

Advanced Biosciences Laboratories (ABL; primary contract holder)

Collaborator

Citations

1. withpower.com withpower.com/trial/phase-healthy-adults-2-2025-e1e68

Bitter Taste Receptor Blockers for Improving Pediatric ... Research shows that adding sodium salts to bitter-tasting medicines can make them taste better and be more acceptable to children, which helps them take their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10881860/

Evaluating palatability in young children: a mini-review ... Abstract. The palatability of pediatric pharmaceutical products plays a crucial role of influencing medication compliance.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12360445/

Poor-tasting pediatric medicines: Part 1. A scoping review of ... Evaluation of medication palatability or acceptability was the primary objective in 15% of studies, typically for antibiotic drug products. In 5 studies, bitter ...

4. frontiersin.org frontiersin.org/journals/drug-delivery/articles/10.3389/fddev.2025.1555522/full

Poor-tasting pediatric medicines: part 2. Exploring ... The results of the study indicate that there is a high perceived need for a taste blocker to aid in administering bitter-tasting pediatric medication.

5. pharmaexcipients.com pharmaexcipients.com/news/poor-tasting-pediatric/

Poor-tasting pediatric medicines: Part 1. A scoping review ... This review highlights the widespread adverse impact of poor-tasting pediatric medicines on patient experiences and outcomes.

6. pharmaexcipients.com pharmaexcipients.com/news/taste-masking-challenge/

Taste Masking Challenge of 155 Active Pharmaceutical ... This retrospective compilation of results of 155 taste assessment studies reveals diversity in aversive flavor attributes of active ingredients.

7. esmed.org esmed.org/MRA/mra/article/download/5890/99193548556/

Taste Masking Challenge of 155 Active Pharmaceutical ... Many Active Pharmaceutical Ingredients (APIs) have an aversive flavor element that can lead to dose rejection or poor compliance, particularly ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0169409X14000349

Playing hide and seek with poorly tasting paediatric ... The aim of this review is to provide an overview of different approaches to taste masking APIs in paediatric oral dosage forms, with a focus on ...