This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Selonabant in Healthy Adult Subjects Aged 18 to 30 Years
This is a Phase 1, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, and PK of single IV doses of selonabant in healthy adult participants between 18 and 25 years of age. The study will enroll up to 5 sequential cohorts of 8 subjects (6 active, 2 placebo) for a total of up to 40 subjects. The starting dose of selonabant will be 1 mg and the planned doses for subsequent cohorts are 2, 5, 10, and 20 mg. The study is supported by a collaborative U01 grant from NIDA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Intravenous infusion of selonabant
Placebo infusion which looks the same as the selonabant infusion
PPD Austin Clinical Research Unit
Austin, Texas, United States
Number of Participants with Adverse Events
Time frame: 28 days
Number of Participants with Clinically Significant Laboratory Test Results
Time frame: 28 days
Number of Participants with Clinically Significant Vital Signs Values
Time frame: 28 days
Number of Participants with Clinically Significant Abnormal ECG Findings
Time frame: 28 days
Number of Participants with Clinically Significant Abnormal Physical Exam Findings
Time frame: 28 days
Change from Baseline in Beck Depression Inventory (BDI)
The minimum possible Beck Depression Inventory (BDI) score is 0, and the maximum score is 63. This score is determined by summing the ratings from the 21 questions, with each question scoring from 0 to 3, indicating the severity of depressive symptoms over the past two weeks. Lower score means less depression
Time frame: 28 days
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) does not have a single minimum or maximum score, as it is not a traditional cumulative-score test. Instead, it uses a series of "yes" or "no" questions to place an individual into distinct categories of risk based on their specific responses. Lower score means less suicidal ideation.
Time frame: 28 days
Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration
Time frame: 28 days
Terminal Elimination Phase Half-life (T1/2)
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Time frame: 28 days
Maximum Observed Concentration (Cmax)
Time frame: 28 days
Pharmacokinetic Clearance (CL)
Pharmacokinetic clearance (\\(CL\\)) is a quantitative measure of how efficiently the body removes a drug from the bloodstream. It is defined as the volume of plasma from which a drug is completely and irreversibly removed per unit of time and is typically expressed in units like milliliters per minute (mL/min) or liters per hour (L/h).
Time frame: 28 days