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

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: OTF 1
Drug: OTF 2
Drug: OTF 3
Drug: OTF 4
Registration Number
NCT04300621
Lead Sponsor
Janssen Research & Development, LLC
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Treatment Sequence 1: OTF 1, 4, 2, 3OTF 3Participants 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.
Treatment Sequence 1: OTF 1, 4, 2, 3OTF 2Participants 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.
Treatment Sequence 3: OTF 3, 2, 4, 1OTF 1Participants 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.
Treatment Sequence 3: OTF 3, 2, 4, 1OTF 2Participants 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.
Treatment Sequence 4: OTF 4, 3, 1, 2OTF 3Participants 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.
Treatment Sequence 1: OTF 1, 4, 2, 3OTF 1Participants 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.
Treatment Sequence 2: OTF 2, 1, 3, 4OTF 1Participants 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.
Treatment Sequence 4: OTF 4, 3, 1, 2OTF 1Participants 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.
Treatment Sequence 1: OTF 1, 4, 2, 3OTF 4Participants 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.
Treatment Sequence 2: OTF 2, 1, 3, 4OTF 2Participants 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.
Treatment Sequence 2: OTF 2, 1, 3, 4OTF 3Participants 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.
Treatment Sequence 3: OTF 3, 2, 4, 1OTF 3Participants 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.
Treatment Sequence 2: OTF 2, 1, 3, 4OTF 4Participants 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.
Treatment Sequence 3: OTF 3, 2, 4, 1OTF 4Participants 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.
Treatment Sequence 4: OTF 4, 3, 1, 2OTF 2Participants 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.
Treatment Sequence 4: OTF 4, 3, 1, 2OTF 4Participants 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.
Primary Outcome Measures
NameTimeMethod
Maximum Plasma Concentration (Cmax)Up to 24 hours

Maximum plasma concentration will be reported.

Area Under the Plasma Concentration-time Curve from Time 0 To Time Of the Last Quantifiable Concentrations [AUC(0-last)]Up to 24 hours

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

Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time [AUC(0-infinity)]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 Outcome Measures
NameTimeMethod
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 blood pressure (Systolic Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\]) will be reported.

Number of Participants with Clinically Significant Abnormalities in Laboratory ParametersDay 1 and 2

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

Number of Participants with Clinically Significant Abnormalities in Vital Sign (Heart Rate)Day 1

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

Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)Day 1 and 2

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

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

Trial Locations

Locations (1)

SGS Life Science Services

🇧🇪

Antwerpen, Belgium

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