Healthy
Conditions
Brief summary
The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.
Interventions
DRUGJNJ-54135419
Single dose of JNJ-54135419 oral solution will be administered sublingually.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) between 20.0 and 28.0 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 that may lead to exclusion will be allowed once during the screening phase * Non-smoker (not smoked for 3 months prior to screening) * A woman must have a negative serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test prior to dosing on Day 1 * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
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, glaucoma, epilepsy 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 * Drinks, on average, more than 5 cups of tea/coffee/cocoa or 8 cans of cola per day * Clinically significant acute illness within 7 days prior to study drug administration * Donation of 1 or more units (approximately 450 milliliter \[mL\]) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of (S)-ketamine | Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose | Observed plasma concentrations of (S)-ketamine will be reported. |
| Plasma Concentrations of Nor-(S)-ketamine | Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose | Observed plasma concentrations of nor-(S)-ketamine will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Vital Sign Abnormalities | Up to 4 Weeks | Number of participants with vital signs (heart rate \[HR\], systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) abnormalities will be reported. |
| Number of Participants with Adverse Events (AEs) | Up to 4 Weeks | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. |
Countries
Belgium
Outcome results
None listed