Taste Assessment Study of SHP429 in Healthy Adult Subjects

Study Overview
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Brief Summary
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The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).

Official Title
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A Phase 1, Open-label, Randomized, 3-period Crossover Taste Assessment Study to Characterize the Palatability of SHP429 When the Contents Are Sprinkled Onto Soft Foods or Emptied Into a Cup and Administered With Water in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mesalamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal, healthy, adult male and female volunteers, without evidence of active or chronic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesalamine (Vanilla Yogurt)<br>One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt | Drug: Mesalamine<br> <br> * Other names: Pentasa, SHP429;|
| Experimental: Mesalamine (Applesauce)<br>One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce | Drug: Mesalamine<br> <br> * Other names: Pentasa, SHP429;|
| Experimental: Mesalamine (Dosing Cup)<br>One 500mg capsule contents emptied into a dosing cup and taken with water | Drug: Mesalamine<br> <br> * Other names: Pentasa, SHP429;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine | 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. | Immediately post-dose | 
| Number of Participants Who Detected an Aftertaste of Mesalamine | 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. | 5 minutes post-dose | 
| Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine | 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. | 5 minutes post-dose | 
| Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis | 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. | Immediately post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced an Adverse Event | Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose. | 4 days | 
| Number of Participants With Potentially Clinically Important Laboratory Results | Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory's normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant. | 1 day | 
| Number of Participants With Potentially Clinically Important Vital Signs | Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important. | 1 day | 
| Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results | Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant. | 1 day |