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
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject is male or female 18 to 30 years of age, inclusive.
. The subject has a body mass index of 18 to 30 kg/m2, inclusive, and with a minimum weight of 50 kg and maximum weight of 110 kg.
. The subject has no clinically significant medical history and no clinically significant findings in vital sign measurements, 12-lead ECG results, and physical examination findings at screening that would pose a risk in study participation, as determined by the investigator. The subject has no clinical laboratory test results outside the reference range that remain out of range after up to 2 repeat tests within the screening window.
. The female subjects must be surgically sterile (ie, hysterectomy and/or oophorectomy) or agree to use a highly effective method of birth control in addition to a secondary barrier method of contraception during the study and for at least 110 days (90 days plus 5 selonabant half-lives, assuming a half-life of 80 hours) after dosing with study treatment.
Exclusion criteria
. The subject is pregnant or lactating.
. The subject has used any prescription (excluding hormonal birth control) or over the counter medications within 14 days or less than 5 half-lives (whichever is longer) of screening and for the entire duration of the study. Exceptions will only be made upon the investigator's decision and discussion with the Sponsor.
. The subject has used any vitamin, mineral, herbal, or dietary supplements within 14 days or less than 5 half-lives (whichever is longer) of screening and for the entire duration of the study. Exceptions will only be made upon the investigator's decision and discussion with the Sponsor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events
Timeframe: 28 days
2
Number of Participants with Clinically Significant Laboratory Test Results
Timeframe: 28 days
3
Number of Participants with Clinically Significant Vital Signs Values
Timeframe: 28 days
4
Number of Participants with Clinically Significant Abnormal ECG Findings
Timeframe: 28 days
5
Number of Participants with Clinically Significant Abnormal Physical Exam Findings
Timeframe: 28 days
6
Change from Baseline in Beck Depression Inventory (BDI)
Timeframe: 28 days
7
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
. The subject has used any cannabis products within 14 days of study drug administration.
. The subject uses any anti-anxiety, anti-depressant, anti-psychotic, anti-epileptic, or anti-migraine medication.
. The subject has a positive urine drug screen result for drugs of abuse at screening or check-in.
. The subject has a history of alcohol abuse or drug addiction within the last year
. The subject's alcohol urine test at screening or check-in was positive. Alcohol will not be allowed for at least 24 hours before screening or check-in until discharge.
Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration