Palatability of a Novel Oral Formulation of Prednsione

NCT02233959 | Completed

• 1 other identifier: Orbis Palatability
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.

Conditions

Palatability

Outcome Measures

Primary Outcomes (1)

• Palatability of a new oral formulation of prednisone

  We will create optimized shelf-stable prednisone microcapsules designed for complete taste-masking followed by immediate release in the stomach. Release characteristics of the TP will be compared to a pharmaceutical grade formulation of prednisone. Milestone: Microencapsulated prednisone that: (i) shows less than 10% coefficient of variance (CV) in the in vitro release profile between fresh and 4-week, 40°C stability-exposed samples while maintaining (ii) maximum of 5% total drug release during the initial 2 minutes and (iii) \>90% release within 30 minutes. N.B. This Specific Aim will be accomplished in the laboratories of Orbis Biosciences, Inc. Upon meeting all milestones associated with this SA, Orbis Biosciences will produce, in accordance with Good Laboratory and Manufacturing Principles, a single batch of TP suitable for use in accomplish SA2.

  Immediately

Secondary Outcomes (1)

• Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP).

  Immediately

Study Arms (1)

Healthy Adults

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32 years of age comprised of a convenience sample who meet study eligibility criteria.

You may qualify if:

• age 18 to 32 years, male and female who are healthy at the time of study
• can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
• demonstrate ability to complete study questionnaire

You may not qualify if:

• history of smoking or using any tobacco products
• previous history of taste disturbance
• any condition or dietary habit known to interfere with the sense of smell and taste
• any structural or functional abnormality of the upper gastrointestinal tract
• ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
• history of any significant illness within the two weeks prior to study
• history of autonomic dysfunction, bronchospastic disease or atopic allergy
• known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
• any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
• brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
• inability to speak and/or read English at a grade 10 level

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• Orbis: collaborator

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

Study Officials

• Gregory L Kearns, Pharm D. PhD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Vice President and Chief Research Officer

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 9, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

US (1)