Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as (S)-ketamine Oral Thin Film
ketamine Thin Film · 1 trial · 1 indication
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.
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.
Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported.
Number of participants with vital signs (Heart Rate and Blood Pressure) abnormalities will be reported.
Observed plasma concentrations of (S)-ketamine will be reported.
Observed plasma concentrations of Nor(S)-ketamine will be reported.
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.
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.
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).
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).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| (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. |
| (S)-ketamine IV Infusion | DRUG | (S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg. |
| Placebo | DRUG | Participants will receive matching placebo. |
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 resul...
Ketamine Thin Film is an investigational oral thin film formulation of ketamine being developed by Johnson & Johnson. It is a small molecule therapeutic candidate that has been studied in a Phase 1 clinical trial in healthy participants. The specific medical conditions it may be intended to treat have not been disclosed.
Ketamine Thin Film targets the NMDA receptor subunits GRIN1, GRIN2A, GRIN2B, GRIN2C, GRIN2D, and GRIN3B. It acts as a negative allosteric modulator at these targets, meaning it reduces receptor activity rather than directly blocking the binding site. This target profile is characteristic of ketamine-based compounds.
Ketamine Thin Film is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor behind the clinical development program for this oral thin film formulation of ketamine.
Ketamine Thin Film is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.
Ketamine Thin Film has been evaluated in one completed Phase 1 trial, NCT03808259, titled A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants. The trial enrolled 96 healthy volunteers in Belgium, was randomized, double-blind, and controlled, and included participants aged 18 years and older.
Yes, ketamine Thin Film is also known as (S)-ketamine Oral Thin Film. Both names refer to the same investigational oral thin film formulation of ketamine that Johnson & Johnson is developing. The (S)-ketamine designation reflects the specific enantiomer used in the formulation.