A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282746
• Other study ID #: CR108751
• Secondary ID: 54135419EDI10022
• Status: Completed
• Phase: Phase 1
• Start date: February 18, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: September 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 17, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-54135419
Single dose of JNJ-54135419 oral solution will be administered sublingually.

Locations

Country	Name	City	State
Belgium	SGS Life Science Services	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentrations of (S)-ketamine	Observed plasma concentrations of (S)-ketamine will be reported.	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
Primary	Plasma Concentrations of Nor-(S)-ketamine	Observed plasma concentrations of nor-(S)-ketamine will be reported.	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	Number of Participants with Vital Sign Abnormalities	Number of participants with vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DBP]) abnormalities will be reported.	Up to 4 Weeks
Secondary	Number of Participants with Adverse Events (AEs)	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.	Up to 4 Weeks