Trial Outcomes & Findings for Taste Assessment Study of SHP429 in Healthy Adult Subjects (NCT NCT02125292)
NCT ID: NCT02125292
Last Updated: 2021-06-03
Results Overview
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.
COMPLETED
PHASE1
18 participants
Immediately post-dose
2021-06-03
Participant Flow
Participant milestones
| Measure |
Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water
Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
|
Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt
Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
|
Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water
Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
|
Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce
Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
|
Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce
Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
|
Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt
Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Hour)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention (1 Hour)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (2 Hours)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout (2 Hours)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Hour)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Intervention (1 Hour)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Intervention (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (1 Hour)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Intervention (1 Hour)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Intervention (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Taste Assessment Study of SHP429 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
|
|---|---|
|
Age, Continuous
|
30.1 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race
White
|
16 Participants
n=5 Participants
|
|
Race
Non-white, black or African American
|
2 Participants
n=5 Participants
|
|
Weight
|
67.59 kilograms
STANDARD_DEVIATION 13.312 • n=5 Participants
|
|
Height
|
166.2 centimeters
STANDARD_DEVIATION 9.25 • n=5 Participants
|
|
Body Mass Index
|
24.348 kg/m^2
STANDARD_DEVIATION 3.4331 • n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post-dosePopulation: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine
|
17 participants
|
16 participants
|
13 participants
|
PRIMARY outcome
Timeframe: 5 minutes post-dosePopulation: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants Who Detected an Aftertaste of Mesalamine
|
0 participants
|
4 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 5 minutes post-dosePopulation: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine
|
0 participants
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Immediately post-dosePopulation: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis
|
18 participants
|
17 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 4 daysPopulation: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
Serious Adverse Event
|
0 participants
|
—
|
—
|
|
Number of Participants Who Experienced an Adverse Event
Non-serious Adverse Event
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Important Laboratory Results
Hematology
|
0 participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Important Laboratory Results
Biochemistry
|
0 participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Important Laboratory Results
Urinalysis
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Important Vital Signs
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 Participants
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results
|
0 participants
|
—
|
—
|
Adverse Events
Mesalamine (Vanilla Yogurt)
Mesalamine (Applesauce)
Mesalamine (Dosing Cup)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mesalamine (Vanilla Yogurt)
n=18 participants at risk
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Applesauce)
n=18 participants at risk
One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
Mesalamine (Dosing Cup)
n=18 participants at risk
One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
|
|---|---|---|---|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • 4 days
|
0.00%
0/18 • 4 days
|
0.00%
0/18 • 4 days
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • 4 days
|
5.6%
1/18 • Number of events 1 • 4 days
|
0.00%
0/18 • 4 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER