HealthyPhase 1NCT02125292

Taste Assessment Study of SHP429 in Healthy Adult Subjects

A Phase 1 study testing Mesalamine in people with Healthy, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Mesalamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 2 Jun 2014to 19 Jun 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: Mesalamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MesalamineDrug
Also called Pentasa, SHP429

Study groups in NCT02125292
Study group	Role	What they receive
Mesalamine (Vanilla Yogurt)	Experimental	One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt Receives: Drug: Mesalamine
Mesalamine (Applesauce)	Experimental	One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce Receives: Drug: Mesalamine
Mesalamine (Dosing Cup)	Experimental	One 500mg capsule contents emptied into a dosing cup and taken with water Receives: Drug: Mesalamine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately post-dose
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.
Measured: 5 minutes post-dose
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.
Measured: 5 minutes post-dose
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.
Measured: Immediately post-dose

Secondary outcomes (4)

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.
Measured: 4 days
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 201419 Jun 2014

First posted29 Apr 2014 (estimated)
Study start2 Jun 2014
Primary completion19 Jun 2014
Study completion19 Jun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02125292
Sponsor's protocol ID: SHP429-102
Status last verified: May 2021
First submitted: 25 Apr 2014
Last updated: 3 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02125292
Acronym / sponsor ID: SHP429-102
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 2 Jun 2014 (actual)
Primary completion: 19 Jun 2014 (actual)
Study completion: 19 Jun 2014 (actual)
First posted: 29 Apr 2014 (estimated)
Results: Posted 20 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Mesalamine (Vanilla Yogurt)	Experimental	Drug: MesalamineOne 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt
Mesalamine (Applesauce)	Experimental	Drug: MesalamineOne 500mg capsule contents sprinkled onto 1 tablespoon of applesauce
Mesalamine (Dosing Cup)	Experimental	Drug: MesalamineOne 500mg capsule contents emptied into a dosing cup and taken with water

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MesalamineAlso: Pentasa, SHP429	Drug	Mesalamine (Applesauce), Mesalamine (Dosing Cup), Mesalamine (Vanilla Yogurt)

Primary outcome

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.
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.
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.
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.

4 secondary outcomes

Number of Participants Who Experienced an Adverse Event
Time frame: 4 days
Number of Participants With Potentially Clinically Important Laboratory Results
Time frame: 1 day
Number of Participants With Potentially Clinically Important Vital Signs
Time frame: 1 day
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results
Time frame: 1 day

Results and safety

Results posted to the registry on 20 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water	3	3
Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt	3	3
Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water	3	3
Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce	3	3
Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce	3	3
Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt	3	3

Primary outcome: Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine

Time frame: Immediately post-dose. Number. Unit: participants

Measure	Mesalamine (Vanilla Yogurt) n = 18	Mesalamine (Applesauce) n = 18	Mesalamine (Dosing Cup) n = 18
Value	17	16	13

Population analysed: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.

Primary outcome: Number of Participants Who Detected an Aftertaste of Mesalamine

Time frame: 5 minutes post-dose. Number. Unit: participants

Measure	Mesalamine (Vanilla Yogurt) n = 18	Mesalamine (Applesauce) n = 18	Mesalamine (Dosing Cup) n = 18
Value	0	4	1

Population analysed: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.

Primary outcome: Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine

Time frame: 5 minutes post-dose. Number. Unit: participants

Measure	Mesalamine (Vanilla Yogurt) n = 18	Mesalamine (Applesauce) n = 18	Mesalamine (Dosing Cup) n = 18
Value	0	3	1

Population analysed: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.

Primary outcome: Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis

Time frame: Immediately post-dose. Number. Unit: participants

Measure	Mesalamine (Vanilla Yogurt) n = 18	Mesalamine (Applesauce) n = 18	Mesalamine (Dosing Cup) n = 18
Value	18	17	18

Population analysed: Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mesalamine (Vanilla Yogurt)	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
Mesalamine (Applesauce)	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
Mesalamine (Dosing Cup)	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mesalamine in people with Healthy, run by Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine (time frame: Immediately post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02125292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.