Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

NCT02263547 | Terminated Phase 1 Results

• 1 other identifier: GZ-2013-11023
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Teriflunomide Elimination; Healthy Volunteers

Keywords

teriflunomide; colestipol hcl

Outcome Measures

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)

  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.

  duration of study about 50 days

Study Arms (1)

teriflunomide elimination with colestipol

OTHER

Drug: teriflunomide; Drug: Colestipol

Interventions

teriflunomide DRUG

Also known as: Aubagio

teriflunomide elimination with colestipol

Colestipol DRUG

teriflunomide elimination with colestipol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Derrick Scott Robertson: lead
• Genzyme, a Sanofi Company: collaborator
• University of South Florida: collaborator

Study Sites (1)

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

MeSH Terms

Interventions

teriflunomide; Colestipol

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

small number of subjects analyzed with some lost to followup

Results Point of Contact

• Title: Assistant Director of Research
• Organization: University of South Florida, COM Neurology

aaungst@health.usf.edu

8139746378

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 13, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 3, 2020
• Results First Posted: July 1, 2019

Record last verified: 2020-04

Locations

US (1)