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

Trial Summary

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 data supports the effectiveness of flavor additives in improving the palatability of pediatric medicines?

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 medicine as needed. This suggests that using flavor additives could be an effective way to improve the taste of pediatric medicines and encourage children to take them. ^{1 2 3 4 5}

Is it safe to use bitter taste receptor blockers in humans?

Bitter taste receptor blockers like sodium acetate, sodium gluconate, and adenosine 5'monophosphate have been shown to have a good safety profile and are generally regarded as safe for use in humans. ^{1 2 6 7 8}

How does this drug improve the taste of pediatric medicine?

This drug uses bitter taste receptor blockers, which are compounds that interact with the molecular pathway of bitterness to reduce the unpleasant taste of medicines. This approach is unique because it directly targets the taste receptors, making it potentially more effective for improving the palatability of bitter medications, especially for children. ^{1 2 6 7 9}

What is the purpose of this trial?

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.

Research Team

Paul M Wise, Ph.D.

Principal Investigator

Monell Chemical Senses Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Age-related differences in bitter taste and efficacy of bitter blockers. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Modification of bitter taste in children. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Taste assessment for paediatric drug Development: A comparison of bitterness taste aversion in children versus Naïve and expert young adult assessors. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacogenetics of taste: turning bitter pills sweet? [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Bitter-blockers as a taste masking strategy: A systematic review towards their utility in pharmaceuticals. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Taste masking technologies in oral pharmaceuticals: recent developments and approaches. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

A new strategy for taste masking of azithromycin antibiotic: development, characterization, and evaluation of azithromycin titanium nanohybrid for masking of bitter taste using physisorption and panel testing studies. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Formulation and development of taste masked fast-disintegrating tablets (FDTs) of Chlorpheniramine maleate using ion-exchange resins. [2013]