The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- Healthy non-smoking male and post-menopausal female subjects
- ...
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- 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
- 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;
- Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
- 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;
- Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
- Females that are pregnant or lactating
- 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
- 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;
- Unable, or unwilling to tolerate multiple venipunctures;
- Positive test results for drugs of abuse at screening;
- Known history of treatment for drug or alcohol addiction within the previous 12 months;
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
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- Healthy non-smoking male and post-menopausal female subjects
- ...
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- 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
- 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;
- Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
- 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;
- Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
- Females that are pregnant or lactating
- 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
- 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;
- Unable, or unwilling to tolerate multiple venipunctures;
- Positive test results for drugs of abuse at screening;
- Known history of treatment for drug or alcohol addiction within the previous 12 months;
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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