Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
racemic ketamine · 1 trial · 1 indication
The abuse potential will be assessed based on visual analog scale (VAS). The VAS score will include for Balancing Measures, Positive and Negative effect at the moment, Perceptual / Dissociative Effects and others).
| Arm | Type | Description |
|---|---|---|
| Sequence 1: Qualification Session | EXPERIMENTAL | Participants will receive Treatment A (intravenous placebo and intranasal placebo concurrently) on Day 1 and Treatment B (0.5 milligram per kilogram (mg/kg) of intravenous racemic ketamine and intranasal placebo concurrently) on Day 2. |
| Sequence 2: Qualification Session | EXPERIMENTAL | Participants will receive Treatment B (0.5 mg/kg of intravenous racemic ketamine and intranasal placebo concurrently) on Day 1 and Treatment A (intravenous placebo and intranasal placebo concurrently) on Day 2. |
| Sequence 3: Treatment Phase | EXPERIMENTAL | Participants in Sequence 3 will receive Treatment A (intravenous placebo and intranasal placebo) on Day 1 of period 1, Treatment D (intravenous placebo and intranasal 112 milligram (mg) of esketamine as 4 devices, each with 28 mg esketamine) on Day 1 of period 2, Treatment B (0.5 mg/kg of intravenous racemic ketamine and intranasal placebo) on Day 1 of period 3, Treatment C (intravenous placebo and intranasal 84 mg esketamine as 3 devices, each with 28 mg esketamine followed by 1 device with placebo) on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 7 to 14 days. |
| Sequence 4: Treatment Phase | EXPERIMENTAL | Participants in Sequence 4 will receive Treatment B on Day 1 of period 1, Treatment A on Day 1 of period 2, Treatment C on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 7 to 14 days. |
| Sequence 5: Treatment Phase | EXPERIMENTAL | Participants in Sequence 5 will receive Treatment C on Day 1 of period 1, Treatment B on Day 1 of period 2, Treatment D on Day 1 of period 3, Treatment A on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 7 to 14 days. |
| Sequence 6: Treatment Phase | EXPERIMENTAL | Participants in Sequence 6 will receive Treatment D on Day 1 of period 1, Treatment C on Day 1 of period 2, Treatment A on Day 1 of period 3, Treatment B on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 7 to 14 days. |
| Name | Type | Description |
|---|---|---|
| Intravenous placebo | DRUG | Participants will receive placebo, 40-minute, intravenous infusion on Day 1 of Sequence 1, on Day 2 of Sequence 2, on Day 1 of Period 1 in Sequence 3, 5 and 6, on Day 1 of Period 2 in Sequence 3, 4 and 6, on Day 1 of Period 3 in Sequence 4, 5 and 6, and on Day 1 of Period 4 in Sequence 3, 4 and 5. |
| Intranasal placebo | DRUG | Participants will receive placebo, intranasally, on Day 1 or Day 2 in Sequence 1 and 2, on Day 1 of Period 1 in Sequence 3 and 4, on Day 1 of Period 2 in Sequence 4 and 5, on Day 1 of Period 3 in Sequence 3 and 6 and on Day 1 of Period 4 in Sequence 5 and 6. |
| Intravenous racemic ketamine | DRUG | Participants will receive 0.5 mg/kg racemic ketamine, intranasally, on Day 2 in sequence 1, on Day 1 in sequence 2, on Day 1 of Period 1 in Sequence 4, on Day 1 of Period 2 in Sequence 5, on Day 1 of Period 3 in Sequence 3, and on Day 1 of Period 4 in Sequence 6. |
| Esketamine 112 mg | DRUG | Participants will receive 112 mg of Esketamine, intranasally, on Day 1 of Period 1 in Sequence 6, on Day 1 of Period 2 in Sequence 3, on Day 1 of Period 3 in Sequence 5, and on Day 1 of Period 4 in Sequence 4. |
| Esketamine 84 mg | DRUG | Participants will receive 84 mg of Esketamine, intranasally, on Day 1 of Period 1 in Sequence 5, on Day 1 of Period 2 in Sequence 6, on Day 1 of Period 3 in Sequence 4, and on Day 1 of Period 4 in Sequence 3. |
Inclusion Criteria: * Participants with body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than 50 kg * Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing ...
Racemic ketamine is being studied for its potential use in drug abuse. It is an investigational small molecule in Phase 1 clinical development. The drug is being evaluated in a clinical trial involving nondependent, recreational drug users to assess its abuse potential.
Racemic ketamine is being developed by Johnson & Johnson (JNJ). The company is conducting clinical research on this investigational drug for the treatment of drug abuse. It is currently in Phase 1 development.
Racemic ketamine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not yet available for clinical use.
Racemic ketamine has one completed clinical trial, NCT02682225, titled 'Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users.' This Phase 1 study enrolled 55 participants in the United States.
Racemic ketamine and esketamine are related but distinct compounds. The clinical trial NCT02682225 compares intranasal esketamine to racemic intravenous ketamine. Racemic ketamine contains both enantiomers of ketamine, while esketamine is a single enantiomer.