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Taste Assessment Study of SHP429 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02125292
Recruitment Status : Completed
First Posted : April 29, 2014
Results First Posted : April 20, 2015
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Mesalamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesalamine (Vanilla Yogurt)
One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt
Drug: Mesalamine
Other Name: Pentasa, SHP429

Experimental: Mesalamine (Applesauce)
One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce
Drug: Mesalamine
Other Name: Pentasa, SHP429

Experimental: Mesalamine (Dosing Cup)
One 500mg capsule contents emptied into a dosing cup and taken with water
Drug: Mesalamine
Other Name: Pentasa, SHP429




Primary Outcome Measures :
  1. Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine [ Time Frame: Immediately post-dose ]
    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.

  2. Number of Participants Who Detected an Aftertaste of Mesalamine [ Time Frame: 5 minutes post-dose ]
    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.

  3. Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine [ Time Frame: 5 minutes post-dose ]
    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.

  4. Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis [ Time Frame: Immediately post-dose ]
    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.


Secondary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event [ Time Frame: 4 days ]
    Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.

  2. Number of Participants With Potentially Clinically Important Laboratory Results [ Time Frame: 1 day ]
    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.

  3. Number of Participants With Potentially Clinically Important Vital Signs [ Time Frame: 1 day ]
    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.

  4. Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results [ Time Frame: 1 day ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal, healthy, adult male and female volunteers, without evidence of active or chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125292


Locations
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United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
Sponsors and Collaborators
Shire
Investigators
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Principal Investigator: Kenneth C Lasseter, MD Clinical Pharmacology of Miami, Inc.

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02125292     History of Changes
Other Study ID Numbers: SHP429-102
First Posted: April 29, 2014    Key Record Dates
Results First Posted: April 20, 2015
Last Update Posted: April 20, 2015
Last Verified: July 2014
Additional relevant MeSH terms:
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Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents