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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
NCT02174250 |
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Date of registration:
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24/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
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Scientific title:
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Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02174250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Amy Zhang, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyowa Hakko Kirin Pharma, Inc. |
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Name:
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Marc Cantillon, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyowa Hakko Kirin Pharma, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Istradefylline 40 mg
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Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only
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Primary Outcome(s)
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Area under the concentration-time curve from time zero to infinity (AUC0 8) and Observed maximum plasma concentration (Cmax) of istradefylline
[Time Frame: Intermittently for a total of 62 days]
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Secondary Outcome(s)
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Number of serious adverse events, and non-serious adverse events
[Time Frame: Continuously for up to 74 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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