A Phase 1 interventional study of teriflunomide and Colestipol in Teriflunomide Elimination and Healthy Volunteers, sponsored by Derrick Scott Robertson. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by Derrick Scott Robertson · Phase 1, Interventional, and Other
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.
This is the only study on the registry with Derrick Scott Robertson as lead sponsor.
Counted across the registry records on this site, refreshed daily.
To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of the baseline visit:
Exclusion Criteria:
Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
Drug: teriflunomide · Drug: Colestipol
Also known as: Aubagio
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
Enrollment occurred from March 2015 through May 2016 at the USF Carol and Frank Morsani Center.
| Milestone | Teriflunomide Elimination With Colestipol |
|---|---|
| Started | 14 |
| Completed | 11 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 2 |
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)
| teriflunomide level (mcg/ml) | Teriflunomide Elimination With Colestipol |
|---|---|
| Primary Outcome Measures: Teriflunomide Concentrations at Day 28 | 9.36 ± 4.26 |
The last blood draw will be about 50 days from the start of the study
| percentage change in teriflunomide level | Teriflunomide Elimination With Colestipol |
|---|---|
| 8 days after colestipol hcl administered | -56.4 ± 21.9 |
| 14 days after colestipol hcl administered | -74.9 ± 27 |
| 26 days after colestipol hcl administered | -94.9 ± 6.3 |
| 36 days after colestipol hcl administered | -96.9 ± 3.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Teriflunomide Elimination With Colestipol | — | 0/14 (0%) | 12/14 (85.7%) |
| Event | Teriflunomide Elimination With Colestipol |
|---|---|
| Anticipated Adverse eventsGastrointestinal disorders | 11/14 |
| Upper Respiratory InfectionInfections and infestations | 4/14 |
| Age, Continuous(years) | Teriflunomide Elimination With Colestipol |
|---|---|
| Mean | 24.5 ± 7.9 |
| Sex: Female, Male(Participants) | Teriflunomide Elimination With Colestipol |
|---|---|
| Female | 4 |
| Male | 10 |
| Race/Ethnicity, Customized(Participants) | Teriflunomide Elimination With Colestipol |
|---|---|
| Caucasian | 7 |
| Black | 2 |
| Asian | 1 |
| Hispanic | 4 |
| BMI(kg/m^2) | Teriflunomide Elimination With Colestipol |
|---|---|
| Mean | 23.9 ± 2.7 |
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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