This is a prospective, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of oral Ketamir-2 in healthy adult participants. The study includes single ascending dose cohorts and multiple ascending dose cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Ketamir-2, also referred to as Ketamir hemipamoate, was administered orally as capsules containing 50 mg or 300 mg. Participants randomized to active treatment received Ketamir-2 according to assigned dose cohort. Cohorts 1 through 4 received a single dose on Day 1. Cohorts 5 through 7 received once-daily dosing from Day 1 through Day 5. Capsules were swallowed together with a glass of water after an overnight fast.
Placebo capsules were identical in appearance to active capsules and were administered orally according to the same number of capsules and dosing schedule as the corresponding Ketamir-2 dose cohort.
Hadassah Clinical Research Unit
Jerusalem, Israel
Number of Participants with Incidence of adverse events
Time frame: From first dose through dosing period until 7 days post last dose
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Clinical laboratory assessments include urinalysis and blood tests. Clinically significant laboratory abnormality is determined by the investigator.
Time frame: From baseline through end of study visit
Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital sign assessments include blood pressure, heart rate, respiratory rate, and oral temperature. Clinically significant vital sign abnormality is determined by the investigator.
Time frame: From baseline through end of study visit
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities on a 12-Lead ECG
Safety ECG will be assessed using 12-lead ECG recordings. Clinically significant abnormality is determined by the investigator.
Time frame: From baseline through end of study visit
Number of Participants With Clinically Significant Physical Examination Findings
A focused physical examination will be performed prior to dosing on Day 1 and upon discharge on Day 2. For cohorts 5-7, a focused physical examination will be performed prior to dosing on Day 1, on Day 3, and Day 6. Examination of the cardiovascular system is mandatory, while the other body systems will be examined at the discretion of the Principal Investigator.
Time frame: From baseline through end of study visit
Number of Participants With Ketamine-Related Side Effects as Assessed by the Ketamine Side Effect Tool (KSET)
The Ketamine Side Effect Tool will be used to assess ketamine-related side effects.
Time frame: From baseline through end of study visit
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Change From Baseline in Bowdle Visual Analog Scale (VAS) Score
The Bowdle VAS is a tool used to measure the psychedelic effects of substances. It consists of 13 items (each scored on 0-100 mm) that assess both internal perception and external perception. Higher scores indicate greater subjective effects.
Time frame: From baseline through end of study visit
Peak Plasma Concentration (Cmax) of Ketamir-2
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6
Percent of Dose Recovered in Urine Over each Collection Period
Urine samples will be obtained prior to first dosing, every 3 hours up to 12 hours post-dose, and 12-24 hours post-dose.
Time frame: Single Ascending Dose cohorts: Day 1 through Day 2; Multiple Ascending Dose cohorts: Day 1 through Day 6