Clinical trial NCT04282746: A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
Official title: An Open-label, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Concentrations of (S)-ketamine
timeFrame: 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
measure: Plasma Concentrations of Nor-(S)-ketamine
timeFrame: 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
Secondary outcomes:
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to 4 Weeks
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 4 Weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Life Science Services
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: