A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

Healthy Clinical Trial

Official title:

An Open-label, Randomized, Four-way Crossover, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300621
• Other study ID #: CR108774
• Secondary ID: 2019-004428-3954
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: September 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 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 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• OTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
• OTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
• OTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
• OTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.

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	Maximum Plasma Concentration (Cmax)	Maximum plasma concentration will be reported.	Up to 24 hours
Primary	Area Under the Plasma Concentration-time Curve from Time 0 To Time Of the Last Quantifiable Concentrations [AUC(0-last)]	Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations will be reported.	Up to 24 hours
Primary	Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time [AUC(0-infinity)]	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.	Up to 24 hours
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital sign (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP])	Number of participants with clinically significant abnormalities in blood pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) will be reported.	Day 1
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital Sign (Heart Rate)	Number of participants with clinically significant abnormalities in vital sign (heart rate) will be reported.	Day 1
Secondary	Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)	Number of participants with clinically significant abnormalities in ECG will be reported.	Day 1 and 2
Secondary	Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters	Number of participants with clinically significant abnormalities in laboratory parameters (Hematology, Clinical chemistry and routine analysis) will be reported.	Day 1 and 2
Secondary	Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability	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.	Up to Day 7