Primary Objective To determine if colestipol hydrochloride tablets can accelerate the elimination of teriflunomide. Teriflunomide will be administered for 14 days followed by colestipol dosing of 11 days. Total duration of the study is 40 days. Secondary Objectives To collect information on the pattern of side effects with use of colestipol hydrochloride after teriflunomide administration and to determine the best duration of therapy needed for adequate elimination
participants will be followed for 40 days to allow for time to administer a loading dose of teriflunomide and observe the elimination of that drug using colestipol hcl.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Primary Outcome Measures: Teriflunomide Concentrations at Day 28
After receiving 14 days of teriflunomide, participants will take 11 days of colestipol to wash out the teriflunomide (measuring the levels of teriflunomide in the blood at each visit)
Time frame: 28 days after the start in the study
Secondary Outcome Measure: Mean Percentage Change of Serum Teriflunomide Levels Percentage Change of Teriflunomide Concentrations at Day 8, Day 14, Day 26 ad Day 36 Following Administration of Colestipol Hydrochloride Tablets.
The last blood draw will be about 50 days from the start of the study
Time frame: duration of study about 50 days
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