The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Istradefylline 40 mg
Rifampin 300mg BID + istradefylline 40mg Day 8 only
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring PD
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
Sites / Locations
- Celerion, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Istradefylline 40mg
Rifampin 300mg BID + istradefylline 40mg
Arm Description
Period 1: Day 1, istradefylline 40mg then crossover to Period 2
Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only
Outcomes
Primary Outcome Measures
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline
Secondary Outcome Measures
Number of serious adverse events, and non-serious adverse events
Full Information
NCT ID
NCT02174250
First Posted
June 24, 2014
Last Updated
September 2, 2015
Sponsor
Kyowa Hakko Kirin Pharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02174250
Brief Title
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Official Title
Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Hakko Kirin Pharma, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
PD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Istradefylline 40mg
Arm Type
Experimental
Arm Description
Period 1: Day 1, istradefylline 40mg then crossover to Period 2
Arm Title
Rifampin 300mg BID + istradefylline 40mg
Arm Type
Experimental
Arm Description
Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only
Intervention Type
Drug
Intervention Name(s)
Istradefylline 40 mg
Other Intervention Name(s)
KW-6002
Intervention Description
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Intervention Type
Drug
Intervention Name(s)
Rifampin 300mg BID + istradefylline 40mg Day 8 only
Other Intervention Name(s)
rifadin
Intervention Description
On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration
Primary Outcome Measure Information:
Title
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline
Time Frame
Intermittently for a total of 62 days
Secondary Outcome Measure Information:
Title
Number of serious adverse events, and non-serious adverse events
Time Frame
Continuously for up to 74 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Cantillon, M.D.
Organizational Affiliation
Kyowa Hakko Kirin Pharma, Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amy Zhang, PhD
Organizational Affiliation
Kyowa Hakko Kirin Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Celerion, Inc.
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
We'll reach out to this number within 24 hrs