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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 6, 2020
First Posted Date  ICMJE March 9, 2020
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE June 19, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: OTF 1
    • Drug: OTF 2
    • Drug: OTF 3
    • Drug: 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.
    Interventions:
    • Drug: OTF 1
    • Drug: OTF 2
    • Drug: OTF 3
    • Drug: 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.
    Interventions:
    • Drug: OTF 1
    • Drug: OTF 2
    • Drug: OTF 3
    • Drug: 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.
    Interventions:
    • Drug: OTF 1
    • Drug: OTF 2
    • Drug: OTF 3
    • Drug: OTF 4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 10, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04300621
Other Study ID Numbers  ICMJE CR108774
2019-004428-39 ( EudraCT Number )
54135419EDI1003 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP