N/A MedDRA version: 20.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Risperidone
Product Name: Risperidon
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISPERIDONE
CAS Number: 106266-06-2
Current Sponsor code: Risperidone
Concentration unit:
Sponsors
Millennium Pharmaceuticals, Inc. A Takeda Oncology Company
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Gender : male 2. Age : 18 to 45 years, inclusive, at screening 3. Body mass index : 18.0 to 30.0 kg/m2, inclusive 4. Body weight : 50 to 100 kg, inclusive 5. Status : healthy right handed subjects 6. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable. 7. All prescribed medication must have been stopped at least 30 days prior to each admission to the clinical research center. 8. All over-the-counter (OTC) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John’s Wort) must have been stopped at least 14 days prior to each admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center. 9. Good physical and mental health as defined by the absence of active or chronic disease based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the PI 10. Completion of an MRI safety questionnaire to verify MRI eligibility (including no claustrophobia, history of surgery involving metal implants, metal body piercing, dentures, dental plates or bridges, any implanted device that is electrically, magnetically, and mechanically activated) and to exclude brain abnormalities that may confound the imaging results (such as history of intracranial mass lesion, brain surgery, hydrocephalus, and/or head injury or trauma). 11. Willing and able to sign the ICF Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Employee of PRA or the Sponsor 2. History of relevant drug and/or food allergies 3. Any contraindication to MRI scanning (eg, claustrophobia, implantable devices) 4. Brain or head abnormalities restricting MRI eligibility 5. Systolic blood pressure 149 mmHg and diastolic blood pressure 90 mmHg 6. Notable resting bradycardia (100bpm) 7. History or presence of clinically significant ECG abnormalities (normal ranges used for healthy subjects eg, a ventricular rate greater than 100 or less than 35 beats/min, PR interval greater than 220 or less than 120 ms, QRS=120 ms, QTcF=430 ms) or cardiovascular disease (eg cardiac insufficiency, coronary artery disease, cardiomyopathy, hypokalemia, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death) 8. Significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) 9. Use of any psychoactive medication, or medications known to have effects on CNS or blood flow 10. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) 11. Habitual caffeine consumption of more than 500 mg per day (approximately more than 6 cups of coffee or equivalent) 12. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) 13. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or each admission to the clinical research center 14. Positive screen for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, or anti human immunodeficiency virus (HIV) 1 and 2 antibodies 15. Participation in a drug study within 90 days prior to drug administration in the current study. Participation in more than 3 other drug studies in the 10 months prior to drug administration in the current study 16. Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the PI 17. Any personal history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures 18. Disorders of the central nervous system, cerebrovascular events, Parkinson’s disease, migraine, depression, bipolar disorder, anxiety, and any other psychiatric disorders or behavioural disturbances 19. Positive family history of psychosis up to 1st degree relatives 20. History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the reproducibility and suitability for multi-center clinical trials of functional MRI blood-oxygen-level dependent (fMRI BOLD) signal during a monetary incentive delay (MID) task and arterial spin labeling (ASL) with and without prior administration of risperidone. Results will be compared to an earlier study at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s College London on a different (GE) scanner platform.;Secondary Objective: Not applicable;Primary end point(s): Endpoints for the MID task are defined as the mean beta value within the right and left ventral striatum for the reward anticipation contrast of interest. ASL results will be taken into account for the interpretation of the MID data. ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Netherlands
Contacts
Public ContactSenior Scientific Director
Millennium Pharmaceuticals, Inc. A Takeda Oncology Company
Outcome results
None listed