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

NCT ID: NCT02174250

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

Brief Summary

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

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Istradefylline 40mg

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

Group Type: EXPERIMENTAL

Istradefylline 40 mg

Intervention Type: DRUG

On Day 1, istradefylline 1 × 40-mg tablet administered alone

Rifampin 300mg BID + istradefylline 40mg

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

Group Type: EXPERIMENTAL

Istradefylline 40 mg

Intervention Type: DRUG

On Day 1, istradefylline 1 × 40-mg tablet administered alone

Rifampin 300mg BID + istradefylline 40mg Day 8 only

Intervention Type: DRUG

On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration

Interventions

Istradefylline 40 mg

On Day 1, istradefylline 1 × 40-mg tablet administered alone

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

KW-6002; rifadin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

Sponsor Role: collaborator

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Cantillon, M.D.

Role: STUDY_CHAIR

Kyowa Hakko Kirin Pharma, Inc.

Amy Zhang, PhD

Role: STUDY_DIRECTOR

Kyowa Hakko Kirin Pharma, Inc.

Locations

Celerion, Inc.

Tempe, Arizona, United States

Countries

United States

Other Identifiers

6002-015

Identifier Type: -

Identifier Source: org_study_id