A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants

Janssen Research & Development, LLC96 enrolled

Overview

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

(S)-ketamine Oral Thin FilmDRUG

(S)-ketamine OTF sublingual formulation at a dose of 7 mg, 14 mg, and 28 mg will be administered in sequential cohorts.

(S)-ketamine IV InfusionDRUG

(S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg.

PlaceboDRUG

Participants will receive matching placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body Mass Index (BMI) between 20 and 28 kilogram per meter square (kg/m\^2), inclusive (BMI=weight/height\^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg * Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase * Participant must be healthy based on physical and neurological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (including QT corrected according to Fridericia's formula \[QTcF\] less than or equal to \[\<=\] 450 milliseconds \[msec\] for males and \<= 470 msec for females) performed at screening. Abnormalities, which are not considered to be of clinical significance by the Investigator, are acceptable. The presence of left bundle branch block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD) will lead to exclusion * Participant must have systolic blood pressure (SBP) and heart rate (HR) within normal limits at screening and at Day -1: supine SBP of at least 90 millimeters of mercury (mmHg) and maximum 150mmHg, supine diastolic blood pressure (DBP) should be above 50mmHg and below 90mmHg and the HR must be between 45 beats per minute (BPM) and 100 BPM. If the results are outside the normal reference ranges above, retesting will be allowed once during the screening phase * Non-smoker (not smoked for 3 months prior to screening) Exclusion Criteria: * Cardiac arrhythmias or other cardiac disease, hematological disease, hypertension, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant * Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies at screening visit * Participant has a history of drug or alcohol use disorder or psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before screening (for example psychotic, bipolar, major depressive, or anxiety disorder) or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission * Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola per day * Clinically significant acute illness within 7 days prior to study drug administration

Locations (1)

Clinical Pharmacology Unit

Merksem, Belgium

Outcomes

Primary Outcomes

Part 1: Change from Baseline in Clinician-Administered Dissociative States Scale (CADSS) Total Score

CADSS is an instrument for the measurement of present-state dissociative symptoms and will be administered to assess treatment-emergent dissociative symptoms. CADSS consists of 23 subjective items, divided into 3 components: depersonalization (items 3 to 7, 20, and 23), derealization (items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (items 14, 15, and 22). The participants responses are coded on a 5-point scale (from 0=not at all to 4=extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.

Time frame: Baseline up to Day 1

Part 2: Change from Baseline in CADSS Total Score

Time frame: Baseline up to Day 1

Part 1: Number of Participants with Vital Sign Abnormalities

Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported.

Time frame: Up to Day 2

Part 2: Number of Participants with Vital Sign Abnormalities

Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported.

Time frame: Up to Day 2

Plasma Concentrations of (S)-ketamine

Observed plasma concentrations of (S)-ketamine will be reported.

Time frame: Part 1: Predose, 1, 3, 5, 10, 15, 30, 40 min, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hour postdose; Part 2: predose, 15, 30 min, 1, 1.6, 2, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours postdose

Data from ClinicalTrials.gov

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