Taste Assessment Study of SHP429 in Healthy Adult Subjects
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
1 other identifier
interventional
18
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Start
First participant enrolled
June 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2014
CompletedResults Posted
Study results publicly available
April 20, 2015
CompletedJune 3, 2021
May 1, 2021
17 days
April 25, 2014
March 12, 2015
May 13, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Number of Participants Who Experienced an Adverse Event
4 days
Number of Participants With Potentially Clinically Important Laboratory Results
1 day
Number of Participants With Potentially Clinically Important Vital Signs
1 day
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results
1 day
Study Arms (3)
Mesalamine (Vanilla Yogurt)
EXPERIMENTALOne 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt
Mesalamine (Applesauce)
EXPERIMENTALOne 500mg capsule contents sprinkled onto 1 tablespoon of applesauce
Mesalamine (Dosing Cup)
EXPERIMENTALOne 500mg capsule contents emptied into a dosing cup and taken with water
Interventions
Eligibility Criteria
You may qualify if:
- normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2014
First Posted
April 29, 2014
Study Start
June 2, 2014
Primary Completion
June 19, 2014
Study Completion
June 19, 2014
Last Updated
June 3, 2021
Results First Posted
April 20, 2015
Record last verified: 2021-05