Clinical trial
Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects
Name
6002-015
Description
The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.
Trial arms
Trial start
2014-06-01
Estimated PCD
2014-08-01
Trial end
2014-12-01
Status
Completed
Phase
Early phase I
Treatment
Istradefylline 40 mg
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Arms:
Istradefylline 40mg, Rifampin 300mg BID + istradefylline 40mg
Other names:
KW-6002
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
Arms:
Rifampin 300mg BID + istradefylline 40mg
Other names:
rifadin
Size
20
Primary endpoint
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-04-25
1 organization
2 products
1 indication
Organization
Kyowa KirinProduct
IstradefyllineIndication
Parkinson's DiseaseProduct
Rifampin + Istradefylline