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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT01605994
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2
* Normal Neurological Exam (LP subjects only: to rule out focal CNS lesions that would render LP unsafe)
* Men and women, ages 18 to 55 years, inclusive.
* Women who are not of childbearing potential (WOCBP) \[ie, who are postmenopausal or surgically sterile\] and men
* Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
* Women must not be breastfeeding
* Sexually active fertile men must use effective birth control if their partners are WOCBP throughout the study and for 90 days after last dose
Exclusion Criteria:
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact upon 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 oral medication
* Inability to be venipunctured and/or tolerate venous access
* Smoking more than 1 cigarette/cigar per week, within 3 months prior to screening
* Regular daily use of nicotine products or Varenicline (Chantix® or Champix®) within 3 months prior to screening
* Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition) \[DSM IV\], Diagnostic Criteria for Drug and Alcohol Abuse
* History of cardiac arrhythmias, or palpitations associated with presyncope or syncope or history of unexplained syncope
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01605994
Study Brief:
Protocol Section:
NCT01605994