A pilot study exploring the reproducibility and suitability for multi-center clinical trials of fMRI bold signal during a monetary incentive delay task and arterial spin labeling with and without prior administration of Risperidone

Millennium Pharmaceuticals, Inc. A Takeda Oncology Company0 sites5 target enrollmentFebruary 20, 2018

Conditions/A MedDRA version: 20.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 100000004848 Therapeutic area: Not possible to specify

DrugsRisperidone

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: /A
Sponsor: Millennium Pharmaceuticals, Inc. A Takeda Oncology Company
Enrollment: 5
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 20, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Millennium Pharmaceuticals, Inc. A Takeda Oncology Company

Eligibility 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).

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 \<90 or \>149 mmHg and diastolic blood pressure \<40 or \>90 mmHg
•6\. Notable resting bradycardia (\<40 beats per min \[bpm]) or tachycardia (\>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)