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The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects

NCT02174250•Kyowa Kirin Co., Ltd.

Summary

The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy non-smoking male and post-menopausal female subjects
•Body Mass Index: 18.0-35.0 kg/m2, inclusive
•Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
•Subjects without clinically significant medical history in the judgment of the investigator
•Subjects without clinically significant laboratory or ECG abnormalities

Exclusion Criteria

•Females that are pregnant or lactating
•Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
•Known history of treatment for drug or alcohol addiction within the previous 12 months;
•Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
•Donated or lost \> 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
•Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
•Positive test results for drugs of abuse at screening;
•Unable, or unwilling to tolerate multiple venipunctures;
•Difficulty fasting or eating the standard meals that will be provided;
•Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit

Locations (1)

Celerion, Inc.

Tempe, Arizona, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

August 1, 2014

Completion Date

December 1, 2014

Last Updated

April 25, 2024

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Istradefylline 40 mg

DRUG

Rifampin 300mg BID + istradefylline 40mg Day 8 only

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGPHASE1

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)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China 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 25, 2024Data 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.

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The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

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

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations