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Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride (TERCOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263547
Recruitment Status : Terminated (PK time points were not being met as expected. Determination that risks outweighed benefit.)
First Posted : October 13, 2014
Results First Posted : July 1, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
University of South Florida
Information provided by (Responsible Party):
Derrick Scott Robertson, University of South Florida

Brief 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


Condition or disease Intervention/treatment Phase
Teriflunomide Elimination Healthy Volunteers Drug: teriflunomide Drug: Colestipol Phase 1

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
teriflunomide elimination with colestipol Drug: teriflunomide
Other Name: Aubagio

Drug: Colestipol



Primary Outcome Measures :
  1. Primary Outcome Measures: Teriflunomide Concentrations at Day 28 [ Time Frame: 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)


Secondary Outcome Measures :
  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. [ Time Frame: duration of study about 50 days ]
    The last blood draw will be about 50 days from the start of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263547


Locations
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United States, Florida
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Derrick Scott Robertson
Genzyme, a Sanofi Company
University of South Florida

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Responsible Party: Derrick Scott Robertson, Assistant Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT02263547     History of Changes
Other Study ID Numbers: GZ-2013-11023
First Posted: October 13, 2014    Key Record Dates
Results First Posted: July 1, 2019
Last Update Posted: September 19, 2019
Last Verified: August 2019
Keywords provided by Derrick Scott Robertson, University of South Florida:
teriflunomide
colestipol hcl
Additional relevant MeSH terms:
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Colestipol
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Sequestering Agents