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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174250
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Istradefylline 40 mg Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: Istradefylline 40mg
Period 1: Day 1, istradefylline 40mg then crossover to Period 2
Drug: Istradefylline 40 mg
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Other Name: KW-6002

Experimental: Rifampin 300mg BID + istradefylline 40mg
Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only
Drug: Istradefylline 40 mg
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Other Name: KW-6002

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
Other Name: rifadin




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of serious adverse events, and non-serious adverse events [ Time Frame: Continuously for up to 74 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174250


Locations
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United States, Arizona
Celerion, Inc.
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
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Study Chair: Marc Cantillon, M.D. Kyowa Hakko Kirin Pharma, Inc.
Study Director: Amy Zhang, PhD Kyowa Hakko Kirin Pharma, Inc.
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Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02174250    
Other Study ID Numbers: 6002-015
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015
Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):
PD
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rifampin
Istradefylline
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs