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

Completed · Phase 1

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT02174250

Run by

Kyowa Kirin Co., Ltd.

People needed

20

Starts

2014-06-01

Expected to finish

2014-12-01

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion, Inc. — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.