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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174250
• Other study ID #: 6002-015
• Status: Completed
• Phase: Phase 1
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline 40 mg
On Day 1, istradefylline 1 × 40-mg tablet administered alone
• Rifampin 300mg BID + istradefylline 40mg Day 8 only
On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve from time zero to infinity (AUC0 8) and Observed maximum plasma concentration (Cmax) of istradefylline		Intermittently for a total of 62 days
Secondary	Number of serious adverse events, and non-serious adverse events		Continuously for up to 74 days