PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)

This is an interventional treatment trial for Methamphetamine Dependence Read More

Inclusion Criteria:

• Subjects must give written informed consent.
• Detoxified METH/COC-dependent male and/or female subjects between 18 and 45.
• Females with Body Mass Index (BMI) of 18-36 kg/m2. Males with BMI of 20-36 kg/m2.
• Subjects in good health determined by screening examination.
• Subject must have adequate veins for intravenous site.
• Subjects must be mentally stable for minimum of 3 months.
• Non-clinically significant hematology clinical laboratory results.
• Subjects must have hematocrit of greater than or equal to 33%.
• Non-clinically significant screening 12-lead ECG and QT interval (time for ventricular depolarization and repolarization to occur) corrected by Fridericia formula (QTcF) of < 440 msec for male and < 460 msec for females.
• Subjects must be right-handed (control for handed-related differences) in lateralized patterns of brain function.
• Ability to identify visual cues during fMRI.
• Subjects' VAS score must be above 20.

Exclusion Criteria:

• Subjects who consume more than 28 units of alcohol per week.
• Subjects who test positive for drugs of abuse or alcohol.
• Current use of nicotine replacement therapy or other smoking cessation treatment.
• Use of other investigational drugs within 30 days, or at least 5 half-lives of a study medication prior to enrollment.
• Subjects being treated with other psychotropic drug will be excluded based on PI's clinical judgment and potential drug-drug adverse reactions with study drugs.
• Subjects on prescribed, over-the-counter (OTC) or nutraceutical drugs that may influence the PK, safety or efficacy profiles of MPh-IR and/or Ond-PR002 will be excluded, or receive a washout prior to study enrollment. Subjects on drugs or substances known to be strong inhibitors or strong inducers of CYP 3A4/5 enzymes (enzymes involved in the metabolism of xenobiotics) or P-glycoprotein (P-gp) will be excluded in a similar manner.
• Subjects with heart disease or uncontrolled high blood pressure.
• Donation of any blood or plasma in the last month, or donation of >500mL of blood within the 3 months preceding study drug administration.
• History of serious adverse reaction or allergies to any drug or any other products used in the study.
• Allergies or intolerance to any of the products used in this study.
• Subjects who have allergies to pork-derived medications or those that contain pork-derived products.
• Inability to give informed consent or high likelihood of being unable to complete the necessary confinement.
• Subjects deemed inappropriate for this study by the Principal Investigator.
• Subjects with a documented brain abnormality, history of unexplained loss of consciousness, seizures, history of unexplained syncope, or history of transient ischemic attack or stroke within the past 6 months.
• History of concurrent illness that required hospitalization within 14 days prior to Day 1 or a clinically significant illness within 4 weeks prior to Day 1.
• History of clinically significant cardiovascular illness within the past 6 months.
• History of clinically significant hepatic, renal, pulmonary, metabolic, endocrine, infectious, gastrointestinal, hematologic, oncologic, retinopathy, or other medical disorders.
• History of unstable psychiatric illness requiring hospitalization within previous 6 months.
• Subjects with history of glaucoma, color blindness or other uncorrected vision problem.
• Subjects with QTcF interval duration greater than or equal to 440 msec (males) or greater than or equal to 460 msec (females) obtained from the 12-lead ECG recorder's measurements on the screening ECG.
• Individuals with a major condition that would make fMRI participation unsafe or uncomfortable.
• Females who are pregnant, breast-feeding or plan on becoming pregnant.
• Subjects who have a hematocrit < 33% or hemoglobin < 12.0 g/dL.