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Also known as Intravenous racemic ketamine
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 a small molecule drug that Johnson & Johnson is developing for drug abuse. It is in Phase 1 clinical development and is being studied in a controlled, randomized, double-blind trial. The drug is also known as intravenous racemic ketamine.
Racemic ketamine is being studied for drug abuse. The Phase 1 trial evaluated its abuse potential in nondependent, recreational drug users. It is not approved for this use and remains investigational.
Johnson & Johnson, ticker JNJ, is developing racemic ketamine. The company is the sponsor of the Phase 1 trial listed for this drug.
Racemic ketamine is in Phase 1 clinical development. The single listed trial, NCT02682225, is completed. The drug is investigational and has not been approved for any indication.
Racemic ketamine has been studied in one Phase 1 trial, NCT02682225, titled a crossover study to evaluate the abuse potential of intranasal esketamine compared to racemic intravenous ketamine in nondependent, recreational drug users. The trial enrolled 55 participants in the United States and is completed.
Yes, racemic ketamine is also known as intravenous racemic ketamine. The alternative name reflects the intravenous route used in the Phase 1 trial NCT02682225.