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

NCT02174250 | Completed Phase 1

• 1 other identifier: 6002-015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

PD

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline

  Intermittently for a total of 62 days

Secondary Outcomes (1)

• Number of serious adverse events, and non-serious adverse events

  Continuously for up to 74 days

Study Arms (2)

Istradefylline 40mg

EXPERIMENTAL

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

Drug: Istradefylline 40 mg

Rifampin 300mg BID + istradefylline 40mg

EXPERIMENTAL

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

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

Interventions

Istradefylline 40 mg DRUG

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

Also known as: KW-6002

Istradefylline 40mg; Rifampin 300mg BID + istradefylline 40mg

Rifampin 300mg BID + istradefylline 40mg Day 8 only DRUG

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

Also known as: rifadin

Rifampin 300mg BID + istradefylline 40mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline; Rifampin; BID protein, human

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Marc Cantillon, M.D.

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY CHAIR

• Amy Zhang, PhD

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (1)