Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Not required
Age
18–25
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy young adults, male or female (non-pregnant and non-lactating), age 18-25 years at time of consent
Have a body mass index (BMI) between 20.0 and 29.0kg/m2
Satisfactory medical assessment with no clinically significant or relevant
Subject must demonstrate a positive response to amphetamine at Screening
You may not be if
A history of current or recurrent disease that could have an effect on the study
Subject has a history of seizures, any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder
Subject has a concurrent chronic or acute illness or other condition that might confound the results of safety assessments or that might increase risk to the subject
Subject has any clinically significant ECG and/or laboratory abnormalities
Subject has a documented allergy, hypersensitivity or intolerance to amphetamines
Subject has been prescribed or has taken amphetamine products in the past, including childhood; recreational use may not be exclusionary per the Investigator's discretion
Subject has a known family history of sudden cardiac death or ventricular arrhythmia
Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine)
Subject has participated in any investigational clinical or vaccine trial within 30 days prior to the first dose of study drug
Subjects is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation
