Taste Assessment Study of SHP429 in Healthy Adult Subjects

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow for 5 periods

Period 1:   First Intervention (1 Hour)

	Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water	Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt	Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water	Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce	Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce	Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Period 2:   Washout (2 Hours)

	Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water	Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt	Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water	Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce	Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce	Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Period 3:   Second Intervention (1 Hour)

	Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water	Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt	Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water	Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce	Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce	Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Period 4:   Washout (2 Hours)

	Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water	Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt	Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water	Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce	Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce	Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Period 5:   Third Intervention (1 Hour)

	Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water	Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt	Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water	Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce	Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce	Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment

Reporting Groups

	Description
All Participants	No text entered.

Baseline Measures

	All Participants
Overall Participants Analyzed  [Units: Participants]	18
Age  [Units: Years] Mean (Standard Deviation)	30.1  (11.31)
Gender  [Units: Participants]
Female	13
Male	5
Ethnicity (NIH/OMB)  [Units: Participants]
Hispanic or Latino	12
Not Hispanic or Latino	6
Unknown or Not Reported	0
Race  [Units: Participants]
White	16
Non-white, black or African American	2
Weight  [Units: Kilograms] Mean (Standard Deviation)	67.59  (13.312)
Height  [Units: Centimeters] Mean (Standard Deviation)	166.2  (9.25)
Body Mass Index  [Units: Kg/m^2] Mean (Standard Deviation)	24.348  (3.4331)

1.  Primary:

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

2.  Primary:

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

3.  Primary:

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

4.  Primary:

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

5.  Secondary:

Number of Participants Who Experienced an Adverse Event   [ Time Frame: 4 days ]

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.