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

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ClinicalTrials.gov Identifier: NCT04300621
Recruitment Status : Completed
First Posted : March 9, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: OTF 1 Drug: OTF 2 Drug: OTF 3 Drug: OTF 4 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 19, 2020
Actual Primary Completion Date : August 10, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Treatment Sequence 1: OTF 1, 4, 2, 3
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
Participants will receive (S)-ketamine administered sublingually through OTF 1.

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

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

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

Experimental: Treatment Sequence 2: OTF 2, 1, 3, 4
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
Participants will receive (S)-ketamine administered sublingually through OTF 1.

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

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

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

Experimental: Treatment Sequence 3: OTF 3, 2, 4, 1
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
Participants will receive (S)-ketamine administered sublingually through OTF 1.

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

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

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

Experimental: Treatment Sequence 4: OTF 4, 3, 1, 2
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
Participants will receive (S)-ketamine administered sublingually through OTF 1.

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300621


Locations
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Belgium
SGS Life Science Services
Antwerpen, Belgium, 2060
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04300621    
Other Study ID Numbers: CR108774
2019-004428-39 ( EudraCT Number )
54135419EDI1003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No