Healthy
Conditions
Brief summary
The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.
Interventions
DRUGOTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
DRUGOTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
DRUGOTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
DRUGOTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 square meters (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 * Nonsmoker (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 on Day -1 of each Period * 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 intervention 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 each study intervention administration * History of clinically significant drug and/or food allergies including known allergies, hypersensitivity, or intolerance to JNJ-54135419 or its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Up to 24 hours | Maximum plasma concentration will be reported. |
| Area Under the Plasma Concentration-time Curve from Time 0 To Time Of the Last Quantifiable Concentrations [AUC(0-last)] | Up to 24 hours | Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations will be reported. |
| Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time [AUC(0-infinity)] | Up to 24 hours | Area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(last) and C(last)/lambda, in which C(last) is the last observed quantifiable concentrations will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Day 1 and 2 | Number of participants with clinically significant abnormalities in laboratory parameters (Hematology, Clinical chemistry and routine analysis) will be reported. |
| Number of Participants with Clinically Significant Abnormalities in Vital sign (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) | Day 1 | Number of participants with clinically significant abnormalities in blood pressure (Systolic Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\]) will be reported. |
| Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability | Up to Day 7 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Number of Participants with Clinically Significant Abnormalities in Vital Sign (Heart Rate) | Day 1 | Number of participants with clinically significant abnormalities in vital sign (heart rate) will be reported. |
| Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs) | Day 1 and 2 | Number of participants with clinically significant abnormalities in ECG will be reported. |
Countries
Belgium
Outcome results
None listed