A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human
Laboratory Model of Smoking Behavior.
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Locations near you
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Full eligibility criteria for NCT02641028
Ages eligible for Study
21 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Provides written informed consent and agrees to complete required clinic visits
Male or female 21 to 60 years of age inclusive
Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
Currently not seeking smoking cessation therapy
In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 12-lead ECG, vital signs, and clinical laboratory testing)
Able to read, write, and speak in English
Females must be either:
Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
Women of childbearing potential (WOCBP) must meet the criteria below:
Uses an acceptable double-barrier method of contraception as determined by the Investigator -and-
Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period.
Male subjects must agree to use a condom if partner is of childbearing potential
Subjects meeting the following criteria are not eligible for the study:
Any substance use disorder other than nicotine or caffeine as assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) substance use disorder checklist in addition to the Mini-International Neuropsychiatric Interview (MINI) (to capture both DSM-V substance use disorder diagnoses)
Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the MINI
Current psychiatric conditions that interfere with study conduct, assessment or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc., without permission of the medical monitor
Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
Clinically significant clinical laboratory test taken during screening, without permission of the Medical Monitor
Elevated AST or ALT ≥ 2 times the upper limit of normal (ULN)
Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
History of severe allergies or multiple adverse drug reactions
Known hypersensitivity to CERC-501
Current use of a proton pump inhibitor or histamine 2 blocker without permission of the Medical Monitor
Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study
All locations for NCT02641028
United States (3)
Vince and Associates
Overland Park, Kansas, United States, 66212
University of Kentucky
Lexington, Kentucky, United States, 40508
New York, New York, United States, 10032
View full eligibility
Tris trial is registered with FDA with number: NCT02641028. The sponsor of the trial is Janssen Research & Development, LLC and it is looking for 71 volunteers for the current phase.
Official trial title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior
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