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

NCT ID: NCT03808259

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-09-04

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Part 1: OTF Sublingual and IV

Participants will receive (S)-ketamine oral thin film (OTF) at a dose of 7 milligram (mg) \[cohort 1\], 14 mg \[cohort 2\], and 28 mg \[cohort 3\] via sublingual route or 14 mg (S)-ketamine intravenous (IV) infusion for 40 minutes or matching placebo in 1 of 3 serial cohorts. Dose escalation decisions to further cohorts of Part 1 will be made based on safety and tolerability profile of the preceding lower dose level.

Group Type: EXPERIMENTAL

(S)-ketamine Oral Thin Film

Intervention Type: DRUG

(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 Infusion

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participants will receive matching placebo.

Part 2: IV Different Infusion Duration

Participants will receive single dose (S)-ketamine less than or equal to (\<=)14 mg IV at a different infusion duration or matching placebo at a different infusion duration. The infusion duration and dose will be chosen after completion of Part 1.

Group Type: EXPERIMENTAL

(S)-ketamine IV Infusion

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participants will receive matching placebo.

Interventions

(S)-ketamine Oral Thin Film

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

Intervention Type: DRUG

(S)-ketamine IV Infusion

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

Intervention Type: DRUG

Placebo

Participants will receive matching placebo.

Intervention Type: DRUG

Other Intervention Names

JNJ-54135419; Ketanest

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2018-003435-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

54135419EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108553

Identifier Type: -

Identifier Source: org_study_id