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| ID | Type | Description | Link |
|---|---|---|---|
| AI 75N93023D00001 | Other Grant/Funding Number | NIH NIAID |
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| Name | Class |
|---|---|
| NIAID, Division of AIDS (contract funder) | UNKNOWN |
| Advanced Biosciences Laboratories (ABL; primary contract holder) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavor additives | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Through study completion, between about 2 months and 3 years, depending on the number of API-flavor combinations individual participants choose to evaluate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul M Wise, Ph.D. | Contact | 267-519-4799 | TasteOfMedicinesStudy@monell.org |
| Name | Affiliation | Role |
|---|---|---|
| Paul M Wise, Ph.D. | Monell Chemical Senses Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monell Chemical Senses Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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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De-identified data will be made available upon publication of results, as consistent with applicable Journal policies. Once available, data will be available indefinitely. Note, however, that individual participants will have the option to opt out of the data-base upon request to the study PI. Once such a request is received, data for the individual participant concerned will no longer be available.
Data will be made available to qualified researchers by the study PI upon request (after publication). If data are placed in managed repositories (e.g., NIH-run managed repository), qualifications will be determined by the managers of the repository
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2025 | Apr 4, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
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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).
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Samples for tasting will be presented with numeric identification codes (no verbal descriptors) and be presented in random order within a tasting session.
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| D020313 |
| Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |