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

NCT04300621 | Completed Phase 1

• 3 other identifiers: CR1087742019-004428-3954135419EDI1003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  Maximum plasma concentration will be reported.

  Up to 24 hours

• 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

• 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 Outcomes (5)

• 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 Vital Sign (Heart Rate)

  Day 1

• Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)

  Day 1 and 2

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

  Day 1 and 2

• Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability

  Up to Day 7

Study Arms (4)

Treatment Sequence 1: OTF 1, 4, 2, 3

EXPERIMENTAL

Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 1 in period 1; followed by OTF 4 in period 2; followed by OTF 2 in period 3; followed by OTF 3 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.

Drug: OTF 1; Drug: OTF 2; Drug: OTF 3; Drug: OTF 4

Treatment Sequence 2: OTF 2, 1, 3, 4

EXPERIMENTAL

Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 2 in period 1; followed by OTF 1 in period 2; followed by OTF 3 in period 3; followed by OTF 4 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.

Drug: OTF 1; Drug: OTF 2; Drug: OTF 3; Drug: OTF 4

Treatment Sequence 3: OTF 3, 2, 4, 1

EXPERIMENTAL

Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 3 in period 1; followed by OTF 2 in period 2; followed by OTF 4 in period 3; followed by OTF 1 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.

Drug: OTF 1; Drug: OTF 2; Drug: OTF 3; Drug: OTF 4

Treatment Sequence 4: OTF 4, 3, 1, 2

EXPERIMENTAL

Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 4 in period 1; followed by OTF 3 in period 2; followed by OTF 1 in period 3; followed by OTF 2 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.

Drug: OTF 1; Drug: OTF 2; Drug: OTF 3; Drug: OTF 4

Interventions

OTF 1 DRUG

Participants will receive (S)-ketamine administered sublingually through OTF 1.

Treatment Sequence 1: OTF 1, 4, 2, 3; Treatment Sequence 2: OTF 2, 1, 3, 4; Treatment Sequence 3: OTF 3, 2, 4, 1; Treatment Sequence 4: OTF 4, 3, 1, 2

OTF 2 DRUG

Participants will receive (S)-ketamine administered sublingually through OTF 2.

Treatment Sequence 1: OTF 1, 4, 2, 3; Treatment Sequence 2: OTF 2, 1, 3, 4; Treatment Sequence 3: OTF 3, 2, 4, 1; Treatment Sequence 4: OTF 4, 3, 1, 2

OTF 3 DRUG

Participants will receive (S)-ketamine administered sublingually through OTF 3.

Treatment Sequence 1: OTF 1, 4, 2, 3; Treatment Sequence 2: OTF 2, 1, 3, 4; Treatment Sequence 3: OTF 3, 2, 4, 1; Treatment Sequence 4: OTF 4, 3, 1, 2

OTF 4 DRUG

Participants will receive (S)-ketamine administered sublingually through OTF 4.

Treatment Sequence 1: OTF 1, 4, 2, 3; Treatment Sequence 2: OTF 2, 1, 3, 4; Treatment Sequence 3: OTF 3, 2, 4, 1; Treatment Sequence 4: OTF 4, 3, 1, 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SGS Life Science Services

Antwerp, 2060, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 9, 2020
• Study Start: June 19, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)