Loading clinical trials...

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

NCT02263547•Derrick Scott Robertson

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

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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
+8 more criteria

Locations (1)

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

April 3, 2020

Enrollment

ACTUAL participants

Conditions

Teriflunomide EliminationHealthy Volunteers

Interventions

teriflunomide

DRUG

Colestipol

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Study of ENX-104 in Healthy Participants

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

Single-dose,First-in-human of KLA478