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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003435-30 | EudraCT Number | ||
| 54135419EDI1001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: OTF Sublingual and IV | Experimental | 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. |
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| Part 2: IV Different Infusion Duration | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (S)-ketamine Oral Thin Film | Drug | (S)-ketamine OTF sublingual formulation at a dose of 7 mg, 14 mg, and 28 mg will be administered in sequential cohorts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Change from Baseline in Clinician-Administered Dissociative States Scale (CADSS) Total Score | 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. | Baseline up to Day 1 |
| Part 2: Change from Baseline in CADSS Total Score | 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. | Baseline up to Day 1 |
| Part 1: Number of Participants with Vital Sign Abnormalities | Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported. | Up to Day 2 |
| Part 2: Number of Participants with Vital Sign Abnormalities | Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported. | Up to Day 2 |
| Plasma Concentrations of (S)-ketamine | Observed plasma concentrations of (S)-ketamine will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
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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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| (S)-ketamine IV Infusion | Drug | (S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg. |
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| Placebo | Drug | Participants will receive matching placebo. |
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| 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 |
| Plasma Concentrations of Nor(S)-ketamine | Observed plasma concentrations of Nor(S)-ketamine will be reported. | 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 |
| Part 1: Change from Baseline in Electroencephalogram (EEG) Power | 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. | Predose (Baseline) and 2.25 hours postdose |
| Part 2: Change from Baseline in EEG Power | 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. | Predose (Baseline) and 3.25 hours postdose |
| Part 1: Change from Baseline in Continuous Paired Associate Learning Test (cPALT) Score | 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). | Baseline up to Day 1 |
| Part 2: Change from Baseline in cPALT Score | 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). | Baseline up to Day 1 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |