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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Istradefylline 40 mg; Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only

Study type: Interventional

Funder types: Industry

Identifiers

NCT02174250

6002-015

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Istradefylline 40mg

Experimental group

Description:

Period 1: Day 1, istradefylline 40mg then crossover to Period 2

Treatment:

Drug: Istradefylline 40 mg

Rifampin 300mg BID + istradefylline 40mg

Experimental group

Description:

Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only

Treatment:

Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only

Drug: Istradefylline 40 mg