Recruitment

Recruitment Status
Completed

Inclusion Criteria

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.
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.
Healthy non-smoking male and post-menopausal female subjects
Subjects without clinically significant laboratory or ECG abnormalities
Subjects without clinically significant medical history in the judgment of the investigator

Exclusion Criteria

Known history of treatment for drug or alcohol addiction within the previous 12 months;
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;
Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
...
Known history of treatment for drug or alcohol addiction within the previous 12 months;
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;
Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
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;
Difficulty fasting or eating the standard meals that will be provided;
Unable, or unwilling to tolerate multiple venipunctures;
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);
Females that are pregnant or lactating

Summary

Conditions
Parkinson's Disease
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criteria

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.
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.
Healthy non-smoking male and post-menopausal female subjects
Subjects without clinically significant laboratory or ECG abnormalities
Subjects without clinically significant medical history in the judgment of the investigator

Exclusion Criteria

Known history of treatment for drug or alcohol addiction within the previous 12 months;
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;
Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
...
Known history of treatment for drug or alcohol addiction within the previous 12 months;
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;
Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
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;
Difficulty fasting or eating the standard meals that will be provided;
Unable, or unwilling to tolerate multiple venipunctures;
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);
Females that are pregnant or lactating

Tracking Information

NCT #
NCT02174250
Collaborators
Not Provided
Investigators
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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