Healthy
Conditions
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).
Interventions
DRUGMesalamine
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis | 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. |
| Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine | 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. |
| Number of Participants Who Detected an Aftertaste of Mesalamine | 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. |
| Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | 4 days | Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose. |
| Number of Participants With Potentially Clinically Important Laboratory Results | 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. |
| Number of Participants With Potentially Clinically Important Vital Signs | 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. |
| Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 30.1 years STANDARD_DEVIATION 11.31 |
| Body Mass Index | 24.348 kg/m^2 STANDARD_DEVIATION 3.4331 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 166.2 centimeters STANDARD_DEVIATION 9.25 |
| Race Non-white, black or African American | 2 Participants |
| Race White | 16 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 5 Participants |
| Weight | 67.59 kilograms STANDARD_DEVIATION 13.312 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 18 | 1 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
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.
Time frame: 5 minutes post-dose
Population: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants Who Detected an Aftertaste of Mesalamine | 0 participants |
| Mesalamine (Applesauce) | Number of Participants Who Detected an Aftertaste of Mesalamine | 4 participants |
| Mesalamine (Dosing Cup) | Number of Participants Who Detected an Aftertaste of Mesalamine | 1 participants |
Primary
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.
Time frame: Immediately post-dose
Population: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis | 18 participants |
| Mesalamine (Applesauce) | Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis | 17 participants |
| Mesalamine (Dosing Cup) | Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis | 18 participants |
Primary
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.
Time frame: 5 minutes post-dose
Population: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine | 0 participants |
| Mesalamine (Applesauce) | Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine | 3 participants |
| Mesalamine (Dosing Cup) | Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine | 1 participants |
Primary
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.
Time frame: Immediately post-dose
Population: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine | 17 participants |
| Mesalamine (Applesauce) | Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine | 16 participants |
| Mesalamine (Dosing Cup) | Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine | 13 participants |
Secondary
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.
Time frame: 4 days
Population: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants Who Experienced an Adverse Event | Serious Adverse Event | 0 participants |
| Mesalamine (Vanilla Yogurt) | Number of Participants Who Experienced an Adverse Event | Non-serious Adverse Event | 2 participants |
Secondary
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.
Time frame: 1 day
Population: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results | 0 participants |
Secondary
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.
Time frame: 1 day
Population: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants With Potentially Clinically Important Laboratory Results | Hematology | 0 participants |
| Mesalamine (Vanilla Yogurt) | Number of Participants With Potentially Clinically Important Laboratory Results | Biochemistry | 0 participants |
| Mesalamine (Vanilla Yogurt) | Number of Participants With Potentially Clinically Important Laboratory Results | Urinalysis | 3 participants |
Secondary
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.
Time frame: 1 day
Population: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | Number of Participants With Potentially Clinically Important Vital Signs | 0 participants |