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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00964912
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
* Right-handed, non-ambidextrous subjects for Part 2
* Men and women, ages 18 to 55 years, inclusive
Exclusion Criteria:
* Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* WOCBP using a prohibited contraceptive method
* Women who are pregnant or breastfeeding
* Sexually active fertile men not using effective birth control if their partners are WOCBP
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* History of cholecystectomy
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact the absorption of study drug
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate/swallow oral medication
* Difficulty with venipuncture and/or poor venous access
* Self-reported smokers
* Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
* Confirmed resting supine systolic blood pressure \> 130 mmHg
* Confirmed resting supine diastolic blood pressure \> 80 mmHg
* Confirmed QT value ≥ 500 msec
* Confirmed QTc (Bazett) value ≥ 450 msec
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
* History of peppermint allergies
* History of brain conditions (e.g. history of stroke, head trauma, etc.)
* History of or current psychiatric conditions
* History of claustrophobia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00964912
Study Brief:
Protocol Section:
NCT00964912