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History of Changes for Study: NCT03808259
A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants
Latest version (submitted September 10, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 16, 2019 None (earliest Version on record)
2 May 29, 2019 Study Status
3 September 10, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03808259
Submitted Date:  January 16, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR108553
Brief Title: A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants
Official Title: A Randomized, Participant- and Investigator Blind, Double Dummy, Placebo- and Comparator-controlled, Single Ascending Dose and Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Modes of (S) Ketamine Administration in Healthy Participants
Secondary IDs: 2018-003435-30 [EudraCT Number]
54135419EDI1001 [Janssen Research & Development, LLC]
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Recruiting
Study Start: December 20, 2018
Primary Completion: May 6, 2019 [Anticipated]
Study Completion: May 6, 2019 [Anticipated]
First Submitted: January 4, 2019
First Submitted that
Met QC Criteria:
January 16, 2019
First Posted: January 17, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 16, 2019
Last Update Posted: January 17, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy participants.
Detailed Description:
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 84 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1: OTF Sublingual and IV
Participants will receive (S)-ketamine oral thin film (OTF) at a dose of 7 milligram (mg) [cohort 1], 14 mg [cohort 2], and 28 mg [cohort 3] via sublingual route or 14 mg (S)-ketamine intravenous (IV) infusion for 40 minutes or matching placebo in 1 of 3 serial cohorts. Dose escalation decisions to further cohorts of Part 1 will be made based on safety and tolerability profile of the preceding lower dose level.
Drug: (S)-ketamine Oral Thin Film
(S)-ketamine OTF sublingual formulation at a dose of 7 mg, 14 mg, and 28 mg will be administered in sequential cohorts.
Other Names:
  • JNJ-54135419
Drug: (S)-ketamine IV Infusion
(S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg.
Other Names:
  • Ketanest
Drug: Placebo
Participants will receive matching placebo.
Experimental: Part 2: IV Different Infusion Duration
Participants will receive single dose (S)-ketamine less than or equal to (<=)14 mg IV at a different infusion duration or matching placebo at a different infusion duration. The infusion duration and dose will be chosen after completion of Part 1.
Drug: (S)-ketamine IV Infusion
(S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg.
Other Names:
  • Ketanest
Drug: Placebo
Participants will receive matching placebo.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Part 1: Change from Baseline in Clinician-Administered Dissociative States Scale (CADSS) Total Score
[ Time Frame: Baseline up to Day 1 ]

CADSS is an instrument for the measurement of present-state dissociative symptoms and will be administered to assess treatment-emergent dissociative symptoms. CADSS consists of 23 subjective items, divided into 3 components: depersonalization (items 3 to 7, 20, and 23), derealization (items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (items 14, 15, and 22). The participants responses are coded on a 5-point scale (from 0=not at all to 4=extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
2. Part 2: Change from Baseline in CADSS Total Score
[ Time Frame: Baseline up to Day 1 ]

CADSS is an instrument for the measurement of present-state dissociative symptoms and will be administered to assess treatment-emergent dissociative symptoms. CADSS consists of 23 subjective items, divided into 3 components: depersonalization (items 3 to 7, 20, and 23), derealization (items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (items 14, 15, and 22). The participants responses are coded on a 5-point scale (from 0=not at all to 4=extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
3. Part 1: Number of Participants with Vital Sign Abnormalities
[ Time Frame: Up to Day 2 ]

Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported.
4. Part 2: Number of Participants with Vital Sign Abnormalities
[ Time Frame: Up to Day 2 ]

Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported.
5. Plasma Concentrations of (S)-ketamine
[ Time Frame: Part 1: Predose, 1, 3, 5, 10, 15, 30, 40 min, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hour postdose; Part 2: predose, 15, 30 min, 1, 1.6, 2, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours postdose ]

Observed plasma concentrations of (S)-ketamine will be reported.
6. Plasma Concentrations of Nor(S)-ketamine
[ Time Frame: Part 1: Predose, 1, 3, 5, 10, 15, 30, 40 min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hour postdose; Part 2: predose, 15, 30 min, 1, 1.6, 2, 3, 3.5, 4, 6, 8, 10, 12 and 24 hours postdose ]

Observed plasma concentrations of Nor(S)-ketamine will be reported.
7. Part 1: Change from Baseline in Electroencephalogram (EEG) Power
[ Time Frame: Predose (Baseline) and 2.25 hours postdose ]

EEG power spectral activity in the alpha 1, alpha 2, beta 1, beta 2, delta, theta and gamma frequency bands will be estimated for the baseline EEG recording and will be compared to the EEG power spectral activity in the same frequency bands.
8. Part 2: Change from Baseline in EEG Power
[ Time Frame: Predose (Baseline) and 3.25 hours postdose ]

EEG power spectral activity in the alpha 1, alpha 2, beta 1, beta 2, delta, theta and gamma frequency bands will be estimated for the baseline EEG recording and will be compared to the EEG power spectral activity in the same frequency bands.
9. Part 1: Change from Baseline in Continuous Paired Associate Learning Test (cPALT) Score
[ Time Frame: Baseline up to Day 1 ]

The cPALT will be used to assess whether drug will improve performance of complex cognitive tasks. CPAL assesses Visual episodic memory (associate learning) cognitive domain. In this task, participants must learn a series of associations between a set of difficult to verbalize patterns (amoeba) and locations. In participants, 14 pattern/location associations must be learned. In the presentation phase of the task the pattern appears at the location and the participant is required to acknowledge that they have seen the pattern by touching the location at which it appears. Patterns are presented in random order. In the learning phase of the task, participants must place each of the 14 patterns in their correct locations. They must do this in 10 rounds. The outcome is number of errors made in correctly placing each of the four patterns in their location four times (Lower score = better performance).
10. Part 2: Change from Baseline in cPALT Score
[ Time Frame: Baseline up to Day 1 ]

The cPALT will be used to assess whether drug will improve performance of complex cognitive tasks. CPAL assesses Visual episodic memory (associate learning) cognitive domain. In this task, participants must learn a series of associations between a set of difficult to verbalize patterns (amoeba) and locations. In participants, 14 pattern/location associations must be learned. In the presentation phase of the task the pattern appears at the location and the participant is required to acknowledge that they have seen the pattern by touching the location at which it appears. Patterns are presented in random order. In the learning phase of the task, participants must place each of the 14 patterns in their correct locations. They must do this in 10 rounds. The outcome is number of errors made in correctly placing each of the four patterns in their location four times (Lower score = better performance).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Body Mass Index (BMI) between 20 and 28 kilogram per meter square (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
  • Participant must be healthy based on physical and neurological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (including QT corrected according to Fridericia's formula [QTcF] less than or equal to [<=] 450 milliseconds [msec] for males and <= 470 msec for females) performed at screening. Abnormalities, which are not considered to be of clinical significance by the Investigator, are acceptable. The presence of left bundle branch block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD) will lead to exclusion
  • Participant must have systolic blood pressure (SBP) and heart rate (HR) within normal limits at screening and at Day -1: supine SBP of at least 90 millimeters of mercury (mmHg) and maximum 150mmHg, supine diastolic blood pressure (DBP) should be above 50mmHg and below 90mmHg and the HR must be between 45 beats per minute (BPM) and 100 BPM. If the results are outside the normal reference ranges above, retesting will be allowed once during the screening phase
  • Non-smoker (not smoked for 3 months prior to screening)

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, 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
  • Participant has a history of drug or alcohol use disorder or psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before screening (for example psychotic, bipolar, major depressive, or anxiety disorder) or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission
  • Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola per day
  • Clinically significant acute illness within 7 days prior to study drug administration
Open or close this module Contacts/Locations
Central Contact Person: Study Contact
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: Belgium
Clinical Pharmacology Unit
[Recruiting]
Merksem, Belgium, 2170
Open or close this module IPDSharing
Plan to Share IPD: 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

Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.janssen.com/clinical-trials/transparency
Open or close this module References
Citations:
Links:
Available IPD/Information:

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