Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

Study Overview
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Brief Summary
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The objective of this study is to compare the acceptability of Colesevelam HCl powder for oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated equivalent cholesterol lowering doses of each comparator drug.

Detailed Description
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In 2009, colesevelam HCl was approved as a powder formulation. Little objective evidence exists comparing the acceptability of colesevelam HCl powder for oral suspension formulation versus other bile acid sequestrant powder formulations. A Bile Acid Sequestrant Acceptability (BASA) Scale was developed and validated as an instrument to compare the acceptability of different bile acid sequestrant preparations

Official Title
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A Randomized, Single-Blind, Single Research Site, Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale in Generally Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cholestyramine
* Drug: Colesevelam HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18-70 years of age In general good health (defined as study participants who are medically stable, meet protocol criteria, but who may also have non-exclusionary ongoing medical conditions). Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf. Subjects are willing and readily able to be contacted for post-study safety phone call assessments one to seven days after the single study visit. Exclusion Criteria: Prior intolerance to bile acid sequestrants Known Phenylketonuria. Colesevelam (Welchol) for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose. Women who are either pregnant, or who are not practicing any form of birth control. Prior gastrointestinal surgery History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea) History of bowel obstruction, malabsorption, or irritable bowel syndrome History of esophageal disease Current or past history of gallbladder disease History of pancreatitis Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to visit 1. Diagnosis of diabetes mellitus Known history of triglyceride levels > 300 mg/dl. History of alcohol or drug abuse within 1 year of study entry Alcohol intake that exceeds more than 2 units of alcohol drinks per day Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 days of visit 1). Any other situation in which the Investigator makes the judgment that participation in the study would not be in the best interest of the study participant, or in the best interest of providing reliable study data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholestyramine 12 grams<br>Cholestyramine 12 grams | Drug: Cholestyramine<br>* Cholestyramine 12 grams, one time dose<br>* Other names: Questran;|
| Active Comparator: Colesevelam HCl<br>Colesevelam HCl, 4 grams | Drug: Colesevelam HCl<br>* Colesevelam HCl, 4 grams, one time dose<br>* Other names: Welchol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. | The bile acid sequestrant acceptability (BASA) scale has 4 scoring categories: taste, texture, appearance, and mixability. Participants rank each category separately. The best possible score for each category is 5, and the worst possible score for each category is 1. | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile Acid Sequestrant, Resin, Lipids, Glucose, Cholesterol, Diabetes Mellitus, Bile Acid Sequestrant Acceptability Scale