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Completed

NCT Number: NCT04300621

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTF 1

Drug

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

OTF 2

Drug

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

OTF 3

Drug

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

OTF 4

Drug

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

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 24 hours

    Maximum plasma concentration will be reported.

  2. Area Under the Plasma Concentration-time Curve from Time 0 To Time Of the Last Quantifiable Concentrations [AUC(0-last)]

    Time frame: Up to 24 hours

    Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations will be reported.

  3. Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time [AUC(0-infinity)]

    Time frame: Up to 24 hours

    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.

Secondary outcomes

  1. Number of Participants with Clinically Significant Abnormalities in Vital sign (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP])

    Time frame: Day 1

    Number of participants with clinically significant abnormalities in blood pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) will be reported.

  2. Number of Participants with Clinically Significant Abnormalities in Vital Sign (Heart Rate)

    Time frame: Day 1

    Number of participants with clinically significant abnormalities in vital sign (heart rate) will be reported.

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

    Time frame: Day 1 and 2

    Number of participants with clinically significant abnormalities in ECG will be reported.

  4. Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

    Time frame: Day 1 and 2

    Number of participants with clinically significant abnormalities in laboratory parameters (Hematology, Clinical chemistry and routine analysis) will be reported.

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

    Time frame: Up to Day 7

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2020
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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