Clinical TrialHealthy VolunteersKetamineCompleted

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

This open-label, randomised, four-way crossover, single dose study (n=16) aimed to investigate the safety, tolerability, and pharmacokinetics of different oral thin film (OTF) formulations of (S)-ketamine for sublingual administration in healthy participants.

Target Enrollment
16 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

Randomised, four-period crossover in healthy adults to characterise plasma pharmacokinetics of four single-dose sublingual oral thin film (S)-ketamine formulations (OTF 1–4) with at least 72 hours washout between periods.

Primary assessments are PK parameters after each single-dose administration; safety and tolerability monitored via labs and clinical assessment. Key eligibility: BMI 20.0–28.0 kg/m^2, weight 60–100 kg, nonsmokers, females require negative pregnancy tests.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

OTF (S)-ketamine

experimental

Four-period randomised crossover comparing four single-dose sublingual OTF formulations (OTF1–OTF4) with ≥72-hour washout between periods.

Interventions

  • Ketamine
    via Sublingual• single dose• 4 doses total

    Four OTF formulations (OTF 1–4); per-formulation doses not specified; primary outcome PK profile.

Participants

Ages
18 – 50
Sexes
Male & Female

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

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment16 participants
  • Timeline
    Start: 2020-06-19
    End: 2020-08-10
  • Compound
    Ketamine
  • Topic
    Healthy Volunteers

Locations

SGS Life Science Services — Antwerp, Belgium

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