Trial Outcomes & Findings for Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride (NCT NCT02263547)

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

28 days after the start in the study

Results posted on

2020-04-03

Participant Flow

Enrollment occurred from March 2015 through May 2016 at the USF Carol and Frank Morsani Center.

Participants were healthy individuals with no significant health history or concomitant medication use.

Participant milestones

Participant milestones
Measure	Teriflunomide Elimination With Colestipol teriflunomide Colestipol
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Teriflunomide Elimination With Colestipol teriflunomide Colestipol
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Teriflunomide Elimination With Colestipol n=14 Participants teriflunomide Colestipol
Age, Continuous	24.5 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants
BMI	23.9 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days after the start in the study

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)

Outcome measures

Outcome measures
Measure	Teriflunomide Elimination With Colestipol n=14 Participants teriflunomide Colestipol
Primary Outcome Measures: Teriflunomide Concentrations at Day 28	9.36 teriflunomide level (mcg/ml) Standard Deviation 4.26

SECONDARY outcome

Timeframe: duration of study about 50 days

The last blood draw will be about 50 days from the start of the study

Outcome measures

Outcome measures
Measure	Teriflunomide Elimination With Colestipol n=14 Participants teriflunomide Colestipol
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. 8 days after colestipol hcl administered	-56.4 percentage change in teriflunomide level Standard Deviation 21.9
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. 14 days after colestipol hcl administered	-74.9 percentage change in teriflunomide level Standard Deviation 27
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. 26 days after colestipol hcl administered	-94.9 percentage change in teriflunomide level Standard Deviation 6.3
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. 36 days after colestipol hcl administered	-96.9 percentage change in teriflunomide level Standard Deviation 3.7

Adverse Events

Teriflunomide Elimination With Colestipol

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Teriflunomide Elimination With Colestipol n=14 participants at risk teriflunomide Colestipol
Gastrointestinal disorders Anticipated Adverse events	78.6% 11/14 • Number of events 11
Infections and infestations Upper Respiratory Infection	28.6% 4/14 • Number of events 4

Additional Information

Assistant Director of Research

University of South Florida, COM Neurology

Phone: 8139746378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60