Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
NCT ID:
NCT02174250
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02174250
Study Brief:
Protocol Section:
NCT02174250