Teriflunomide EliminationPhase 1TERCOLNCT02263547
Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride
A Phase 1 study testing teriflunomide and Colestipol in people with Teriflunomide Elimination and Healthy Volunteers, run by Derrick Scott Robertson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Teriflunomide Elimination, Healthy Volunteers
- What is being tested?
- teriflunomide and Colestipol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of the baseline visit:
- 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.
- Healthy volunteer*
- Aged 18-45 years, inclusive
- 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.
Who cannot join
- Current smoker or past history as smoker.
- 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
- Participant unlikely to comply with protocol as determined by Investigator, eg, uncooperative attitude, inability to return for follow-up visits
- 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
- Persistent significant or severe infection, either acute or chronic
- 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)
Show all 18Show fewer
- 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
- Prior use of any investigational drug in the preceding 6 months
- 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).
- Pregnant or breast-feeding women or those who plan to become pregnant during the study
- 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.
- Participants wishing to parent children (be a partner in the conception of a child) during the course of the trial.
- 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)
- Any known history of severe preexisting constipation
- History of swallowing disorder or difficulty swallowing
Trial locations and contacts
1 site in 1 country.
United States1 site
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
About this study
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.
- Conditions
- Teriflunomide Elimination, Healthy Volunteers
- Being tested
- teriflunomide, Colestipol
- Keywords
- teriflunomide, colestipol hcl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teriflunomideDrug
Also called Aubagio
ColestipolDrug
| Study group | Role | What they receive |
|---|---|---|
| teriflunomide elimination with colestipol | Other | Not described Receives: Drug: teriflunomide; Drug: Colestipol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: duration of study about 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: PK time points were not being met as expected. Determination that risks outweighed benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Teriflunomide EliminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derrick Scott Robertson
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, University of South Florida
- Responsible party
- Sponsor-investigator, Derrick Scott Robertson, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263547
- Sponsor's protocol ID
- GZ-2013-11023
- Acronym
- TERCOL
- Status last verified
- Apr 2020
- First submitted
- 30 Sep 2014
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride
- ClinicalTrials.gov ID
- NCT02263547
- Acronym / sponsor ID
- TERCOL / GZ-2013-11023
- Conditions
- Teriflunomide Elimination, Healthy Volunteers
- Keywords
- teriflunomide, colestipol hcl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PK time points were not being met as expected. Determination that risks outweighed benefit.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Derrick Scott RobertsonUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, University of South Florida
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teriflunomide elimination with colestipol | Other | Drug: teriflunomide, Drug: Colestipol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of the baseline visit:
- 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.
- Healthy volunteer*
- Aged 18-45 years, inclusive
- 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.
Key exclusion criteria (18 listed)
- Current smoker or past history as smoker.
- 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
- Participant unlikely to comply with protocol as determined by Investigator, eg, uncooperative attitude, inability to return for follow-up visits
- 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
- Persistent significant or severe infection, either acute or chronic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teriflunomideAlso: Aubagio | Drug | teriflunomide elimination with colestipol |
| Colestipol | Drug | teriflunomide elimination with colestipol |
Primary outcome
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)
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing teriflunomide and Colestipol in people with Teriflunomide Elimination and Healthy Volunteers, run by Derrick Scott Robertson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures: Teriflunomide Concentrations at Day 28 (time frame: 28 days after the start in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.