Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02096458
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn	Drug: Dexlansoprazole	Phase 1

Detailed Description

The drug being tested in this study is called dexlansoprazole. An orally disintegrating (OD) form of dexlansoprazole is being tested to look at the average time that it takes for one tablet to disintegrate in the mouth of healthy volunteers. At the point at which the panelist would normally swallow the granules, they will record the time and expectorate the disintegrated tablet mass and not actually swallow the tablet or granules.

The study will enroll approximately 8 healthy volunteers. All participants will take one dexlansoprazole 30 mg OD tablet on up to three separate study days. No more than 60 mg of dexlansoprazole will be tested in any one day.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is approximately 2 weeks. Participants will make up to 4 visits to the clinic, and will be contacted by telephone approximately 1 week after last dose of study drug for a follow-up assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexlansoprazole 30 mg Dexlansoprazole 30 mg delayed-release orally disintegrating tablets at Assessment 1 Day 1, Assessment 2 Day 1, and Assessment 3 Day 1.	Drug: Dexlansoprazole; Dexlansoprazole delayed-release orally disintegrating tablets

Outcome Measures

Primary Outcome Measures

1. Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets [Day 1]

   The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The male or female sensory panelist is between 25 and 80 years of age (inclusive), healthy volunteers for study participation, and is able to read, understand, and sign and date a written informed consent form (ICF) and any required privacy authorization before study participation.

2. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

3. The sensory panelist is qualified based on documented training and experience: All panelists will be provided by Senopsys, LLC: Panelists have been trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations and to measure oral disintegration times. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing product testing.

Exclusion Criteria:

1. Has a history of any illness that, in the opinion of the investigator or the sensory panelist's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the sensory panelist. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; recent history of disease involving head, neck, esophagus (especially malignancy, radiation therapy, fungal infection where taste perception can be altered) or history of mental disease.

2. If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study.

3. Has a known hypersensitivity to dexlansoprazole or any component of dexlansoprazole delayed-release orally disintegrating (OD) tablet or proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).

4. Is currently taking any contraindicated medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Woburn	Massachusetts	United States	01801

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director Clinical Science, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02096458
• Other Study ID Numbers: TAK-390MR(OD)_107; U1111-1152-9255
• First Posted: Mar 26, 2014
• Last Update Posted: Mar 6, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Takeda: Drug therapy
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis; Heartburn; Dexlansoprazole; Lansoprazole

Study Results

Participant Flow

Recruitment Details	A total of 8 participants were screened for the study, and all participants subsequently enrolled.

Arm/Group Title	Dexlansoprazole
Arm/Group Description	Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dexlansoprazole
Arm/Group Description	Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
Overall Participants	8
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	56.5
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%

Outcome Measures

1. Primary Outcome

Title	Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets
Description	The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

The populations consisted of all enrolled participants.

Arm/Group Title	Dexlansoprazole
Arm/Group Description	Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
Measure Participants	8
Mean (Full Range) [Seconds]	36.0

Adverse Events

Time Frame	Up to Day 10
Arm/Group Title	Dexlansoprazole
Arm/Group Description	Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
All Cause Mortality
	Dexlansoprazole
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dexlansoprazole
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Dexlansoprazole
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.