Observed plasma concentrations of (S)-ketamine will be reported.
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
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.
Intervention / Treatment
-
JNJ-54135419 (DRUG)Single dose of JNJ-54135419 oral solution will be administered sublingually.
Condition or Disease
- Healthy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 50 Years |
| Enrollment: | 17 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | N/A |
| Primary Purpose: | Other |
Masking |
|
Clinical Trial Dates
| Start date: | Feb 18, 2020 | ACTUAL |
|---|---|---|
| Primary Completion: | Aug 11, 2020 | ACTUAL |
| Completion Date: | Aug 17, 2020 | ACTUAL |
| Study First Posted: | Feb 25, 2020 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Sep 14, 2021 |
Sponsors / Collaborators
Lead Sponsor:
Janssen Research & Development, LLC
Lead sponsor is responsible party
Responsible Party:
N/A
Location
Participant Groups
-
Participants will receive a single oral dose of JNJ-54135419-AAA oral solution for sublingual administration in 1 of 3 serial dose escalating cohorts in fasted conditions.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 50 |
| Age Groups: | Adult |
| 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
* 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
Primary Outcomes
-
-
Observed plasma concentrations of nor-(S)-ketamine will be reported.
Secondary Outcomes
-
Number of participants with vital signs (heart rate \[HR\], systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) abnormalities will be reported.
-
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.
More Details
| NCT Number: | NCT04282746 |
|---|---|
| Other IDs: | CR108751 |
| Study URL: | https://clinicaltrials.gov/study/NCT04282746 |
Last updated: Sep 29, 2023