Parkinson's Disease
Conditions
Keywords
PD
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.
Interventions
On Day 1, istradefylline 1 × 40-mg tablet administered alone
DRUGRifampin 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
Sponsors
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Kirin Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of serious adverse events, and non-serious adverse events | Continuously for up to 74 days |
Countries
United States
Outcome results
None listed