NCT02125292

Taste Assessment Study of SHP429 in Healthy Adult Subjects

Completed Phase 1 Results posted Last updated 3 June 2021

What this trial tests

Phase 1 trial testing Mesalamine in Healthy in 18 participants. Completed in 19 June 2014.

Timeline

2 June 2014

Primary endpoint
19 June 2014

19 June 2014

Quick facts

Lead sponsor	Shire
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	18
Start date	2 June 2014
Primary completion	19 June 2014
Estimated completion	19 June 2014
Sites	1 location across United States

Drugs / interventions tested

• Mesalamine — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine Primary · 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.

Group	Value	95% CI
Mesalamine (Vanilla Yogurt)	17
Mesalamine (Applesauce)	16
Mesalamine (Dosing Cup)	13

Number of Participants Who Detected an Aftertaste of Mesalamine Primary · 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.

Group	Value	95% CI
Mesalamine (Vanilla Yogurt)	0
Mesalamine (Applesauce)	4
Mesalamine (Dosing Cup)	1

Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine Primary · 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.

Group	Value	95% CI
Mesalamine (Vanilla Yogurt)	0
Mesalamine (Applesauce)	3
Mesalamine (Dosing Cup)	1

Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis Primary · 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.

Group	Value	95% CI
Mesalamine (Vanilla Yogurt)	18
Mesalamine (Applesauce)	17
Mesalamine (Dosing Cup)	18

Number of Participants Who Experienced an Adverse Event Secondary · 4 days

Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.

Serious Adverse Event

Group	Value	95% CI
All Participants	0

Non-serious Adverse Event

Group	Value	95% CI
All Participants	2

Number of Participants With Potentially Clinically Important Laboratory Results Secondary · 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.

Hematology

Group	Value	95% CI
All Participants	0

Biochemistry

Group	Value	95% CI
All Participants	0

Urinalysis

Group	Value	95% CI
All Participants	3

Number of Participants With Potentially Clinically Important Vital Signs Secondary · 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.

Group	Value	95% CI
All Participants	0

Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results Secondary · 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.

Group	Value	95% CI
All Participants	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mesalamine (Vanilla Yogurt)

Serious: 0/18 (0%)

Deaths: —

Mesalamine (Applesauce)

Serious: 0/18 (0%)

Deaths: —

Mesalamine (Dosing Cup)

Serious: 0/18 (0%)

Deaths: —

Other adverse events (2 terms — click to expand)

Reaction	System	Mesalamine (Vanilla Yogurt)	Mesalamine (Applesauce)	Mesalamine (Dosing Cup)
Fatigue	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT02125292 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.