Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

NCT02263547 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-04-03

Study results available
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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

Interventions

DRUG

teriflunomide

DRUG

Colestipol

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY
  • University of South Florida

    collaborator OTHER
  • Derrick Scott Robertson

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263547 on ClinicalTrials.gov