Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mesalamine · 1 trial · 1 indication
A taste assessment was completed immediately after investigational product was administered to assess the subject's taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement "The taste was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered "Yes" or "No" to the following question: "Was there an aftertaste?" The number of participants who answered "Yes" is reported.
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement "The aftertaste (if present) was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
The participants were asked to answer "Yes" or "No" to the following question: "Would you be willing to take medicine this way on a regular basis if necessary?" The number of participants who answered "Yes" is reported.
| Arm | Type | Description |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | EXPERIMENTAL | One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt |
| Mesalamine (Applesauce) | EXPERIMENTAL | One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce |
| Mesalamine (Dosing Cup) | EXPERIMENTAL | One 500mg capsule contents emptied into a dosing cup and taken with water |
| Name | Type | Description |
|---|---|---|
| Mesalamine | DRUG | - |
Inclusion Criteria: * normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
Mesalamine is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial assessing its taste profile. The drug is being developed by Takeda Pharmaceutical Company Limited (TAK).
Mesalamine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this small molecule drug, which is currently in Phase 1 development.
Mesalamine is in Phase 1 clinical development. It has one completed trial, NCT02125292, which was a taste assessment study in healthy adult subjects. The drug is investigational and has not been approved for any indication.
Mesalamine has one clinical trial, NCT02125292, titled 'Taste Assessment Study of SHP429 in Healthy Adult Subjects.' This Phase 1 study was completed in the United States and enrolled 18 healthy volunteers aged 18 years and older.
Mesalamine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a taste assessment study in healthy subjects, and the drug has not progressed to later-stage trials or regulatory approval.