Phase 1
N=18
Taste Assessment Study of SHP429 in Healthy Adult Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02125292 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine — 17; 16; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Mesalamine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine |
17; 16; 13 | — |
| PRIMARY Number of Participants Who Detected an Aftertaste of Mesalamine |
0; 4; 1 | — |
| PRIMARY Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine |
0; 3; 1 | — |
| PRIMARY Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis |
18; 17; 18 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event |
0; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Laboratory Results |
0; 0; 3 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Vital Signs |
— | — |
| SECONDARY Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results |
— | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
Data sourced from ClinicalTrials.gov (NCT02125292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.