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TerminatedNCT02263547TERCOLUpdated Apr 3, 2020Results posted

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

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

Why this study was terminated
PK time points were not being met as expected. Determination that risks outweighed benefit.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Teriflunomide Elimination
  • Healthy Volunteers

Keywords

  • teriflunomide
  • colestipol hcl
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In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of the baseline visit:

  1. Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
  2. Healthy volunteer*
  3. Aged 18-45 years, inclusive
  4. Body Mass Index of 18-29 kg/m2 (body weight of 40-85 kg for women and 50-95 kg for men) *Healthy volunteer is defined as free of concomitant medications and use of either treatment, as deemed by the Investigator, is not contraindicated with any past medical history of the participant.

Exclusion criteria

Exclusion Criteria:

  1. Current smoker or past history as smoker.
  2. Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
  3. Participant unlikely to comply with protocol as determined by Investigator, eg, uncooperative attitude, inability to return for follow-up visits
  4. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
  5. Persistent significant or severe infection, either acute or chronic
  6. Recent history of drug or alcohol abuse within that past 6 months (participants will be asked to refrain from alcohol and drug use during the course of the study)
  7. Participant is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof, directly involved in the conduct of the protocol
  8. Prior use of any investigational drug in the preceding 6 months
  9. Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
  10. Pregnant or breast-feeding women or those who plan to become pregnant during the study
  11. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
  12. Participants wishing to parent children (be a partner in the conception of a child) during the course of the trial.
  13. Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):

    • Hematocrit \< 35% and/or
    • Absolute white blood cell count \< 3000 cells/mm3 (μL) and/or
    • Platelet count \< 150 000 cells/mm3 (μL) and/or- Absolute neutrophil ≤ 1500 cells/mm3 (μL)
  14. Any known history of severe preexisting constipation
  15. History of swallowing disorder or difficulty swallowing
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Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    teriflunomide elimination with colestipol

    Drug: teriflunomide · Drug: Colestipol

Interventions

  • Drugteriflunomide

    Also known as: Aubagio

  • DrugColestipol
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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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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Results

Posted Jul 1, 2019
Limitations and caveats
small number of subjects analyzed with some lost to followup

Participant flow

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

Participant flow — Overall Study
MilestoneTeriflunomide Elimination With Colestipol
Started14
Completed11
Not completed3
Withdrew: Adverse event1
Withdrew: Lost to follow-up2

Outcome measures

PrimaryPrimary 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
Reported as:
Mean · teriflunomide level (mcg/ml)
Primary Outcome Measures: Teriflunomide Concentrations at Day 28
teriflunomide level (mcg/ml)Teriflunomide Elimination With Colestipol
Primary Outcome Measures: Teriflunomide Concentrations at Day 289.36 ± 4.26
SecondarySecondary 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
Reported as:
Mean · percentage change in teriflunomide level
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.
percentage change in teriflunomide levelTeriflunomide 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

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Teriflunomide Elimination With Colestipol—0/14 (0%)12/14 (85.7%)
Most frequent other events
Most frequent other events
EventTeriflunomide Elimination With Colestipol
Anticipated Adverse eventsGastrointestinal disorders11/14
Upper Respiratory InfectionInfections and infestations4/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)Teriflunomide Elimination With Colestipol
Mean24.5 ± 7.9
Sex: Female, Male
Sex: Female, Male(Participants)Teriflunomide Elimination With Colestipol
Female4
Male10
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Teriflunomide Elimination With Colestipol
Caucasian7
Black2
Asian1
Hispanic4
BMI
BMI(kg/m^2)Teriflunomide Elimination With Colestipol
Mean23.9 ± 2.7
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Study locations

1 site
  • USF Carol and Frank Morsani Center for Advanced Healthcare
    Tampa, Florida 33612, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02263547
Lead sponsor
Derrick Scott Robertson
Collaborators
Genzyme, a Sanofi Company, University of South Florida
Responsible party
Derrick Scott Robertson (Assistant Professor, University of South Florida) — Sponsor-investigator
First posted
Oct 13, 2014
Start date
Mar 2015
Primary completion
Jun 2016
Completion
Jun 2016
Results posted
Jul 1, 2019
Last update
Apr 3, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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