HealthyPhase 1NCT04300621
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
A Phase 1 study testing OTF 1, OTF 2 and OTF 3 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OTF 1, OTF 2 and OTF 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 2020to 10 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- OTF 1, OTF 2, OTF 3, OTF 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTF 1Drug
Participants will receive (S)-ketamine administered sublingually through OTF 1.
OTF 2Drug
Participants will receive (S)-ketamine administered sublingually through OTF 2.
OTF 3Drug
Participants will receive (S)-ketamine administered sublingually through OTF 3.
OTF 4Drug
Participants will receive (S)-ketamine administered sublingually through OTF 4.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: OTF 1; Drug: OTF 2; Drug: OTF 3; Drug: OTF 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration will be reported.
Measured: 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.
Measured: 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.
Measured: 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])
Number of participants with clinically significant abnormalities in blood pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) will be reported.
Measured: Day 1
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.
Measured: Day 1
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Number of participants with clinically significant abnormalities in ECG will be reported.
Measured: Day 1 and 2
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.
Measured: Day 1 and 2
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.
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start19 Jun 2020
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300621
- Sponsor's protocol ID
- CR108774
- Other IDs
- 2019-004428-39, 54135419EDI1003, 2019
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04300621
- Acronym / sponsor ID
- CR108774
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1: OTF 1, 4, 2, 3 | Experimental | Drug: OTF 1, Drug: OTF 2, Drug: OTF 3, Drug: OTF 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, 4 | Experimental | Drug: OTF 1, Drug: OTF 2, Drug: OTF 3, Drug: OTF 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, 1 | Experimental | Drug: OTF 1, Drug: OTF 2, Drug: OTF 3, Drug: OTF 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, 2 | Experimental | Drug: OTF 1, Drug: OTF 2, Drug: OTF 3, Drug: OTF 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTF 1Participants will receive (S)-ketamine administered sublingually through OTF 1. | Drug | 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 2Participants will receive (S)-ketamine administered sublingually through OTF 2. | Drug | 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 3Participants will receive (S)-ketamine administered sublingually through OTF 3. | Drug | 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 4Participants will receive (S)-ketamine administered sublingually through OTF 4. | Drug | 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 |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 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)]
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.
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.
5 secondary outcomes
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 Vital Sign (Heart Rate)
Time frame: Day 1
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Time frame: Day 1 and 2
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Day 1 and 2
Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTF 1, OTF 2 and OTF 3 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: Up to 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.