drugset / Trial / NCT02263547
Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride
Phase 1
Terminated
14 enrolled
Derrick Scott Robertson
Genzyme, a Sanofi Company · collabUniversity of South Florida · collab
NaSingle-groupOpen-labelOther
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
Timeline
- Start
- 2015-03
- Primary completion
- 2016-06
- Completion
- 2016-06
Outcome
Outcome not reported
Stopped: “PK time points were not being met as expected. Determination that risks outweighed benefit.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colestipol | Unknown | — | — |
| Subject | Teriflunomide | Small molecule | — | — |
Indications
No indication recorded.