Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-39393406 · 3 trials · 3 indications
Brief Assessment of Cognition (BACS)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC\[t\]) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
The Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC\[t\]) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
The AUC(infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
The AUC(infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.
Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
For cognitive testing a computerized test battery will be applied, focusing on memory, executive function and attention.
For cognitive testing a computerized test battery will be applied, focusing on memory, executive function and attention.
| Arm | Type | Description |
|---|---|---|
| JNJ-39393406 | EXPERIMENTAL | 2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial. |
| Placebo | PLACEBO_COMPARATOR | 2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial. |
| Part A: Cohort 1 | EXPERIMENTAL | 8 participants will be included in this cohort. 6 participants will receive a single dose of 50 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days. |
| Part A: Cohort 2 | EXPERIMENTAL | 8 participants will be included in this cohort. 6 participants will receive a single dose of 150 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days. |
| Part A: Cohort 3 | EXPERIMENTAL | 8 participants will be included in this cohort. 6 participants will receive a single dose of 450 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days. |
| Part A: Cohort 4 | EXPERIMENTAL | 8 participants will be included in this cohort. 6 participants will receive a single dose of 1,350 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days. |
| Part A: Cohort 5 | EXPERIMENTAL | 8 participants will be included in this cohort. 6 participants will receive a single dose of 2,700 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days. |
| Part B: Cohort A | EXPERIMENTAL | 16 participants will be included in this cohort. 12 participants will receive a single dose of JNJ-39393406 selected based on the pharmacokinetic (PK) data from Part A of the study and 4 participants will receive placebo for 13 consecutive days. |
| Part B: Cohort B | EXPERIMENTAL | 16 participants will be included in this cohort. 12 participants will receive a single dose of JNJ-39393406 selected based on the PK data from Part A of the study and 4 participants will receive placebo for 13 consecutive days. |
| Part B: Cohort C | EXPERIMENTAL | 16 participants will be included in this cohort. 12 participants will receive a single dose of JNJ-39393406 selected based on the PK data from Part A of the study and 4 participants will receive placebo for 13 consecutive days. |
| Name | Type | Description |
|---|---|---|
| JNJ-39393406 | DRUG | JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial |
| Placebo | DRUG | JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial |
Inclusion Criteria: 1. Meet DSM V criteria for history of MDD or BPD by MINI. 2. Between 18-50 years of age, male or female subjects of any race, smokers and non-smokers. 3. Able to provide informed consent. All participant patients must have signed an informed consent document indicating they unde...
JNJ-39393406 is an investigational small molecule being studied for the treatment of depression. It has also been evaluated in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. The drug is developed by Johnson & Johnson and is currently in Phase 2 clinical development.
JNJ-39393406 is developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is being investigated for use in depression and has completed early-stage clinical trials in healthy volunteers.
JNJ-39393406 is in Phase 2 clinical development. It has completed one Phase 2 trial investigating its effects on psychometric performance and residual depressive symptoms in patients with depression. The drug is not approved and remains investigational.
JNJ-39393406 has been studied in three completed clinical trials. NCT01556217 and NCT02023255 were Phase 1 trials in healthy volunteers, while NCT02677207 was a Phase 2 trial in patients with depression. The Phase 2 trial enrolled 80 participants and was conducted in Moldova and Romania.
JNJ-39393406 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for depression. The drug has completed clinical trials, but no approval has been granted, and it remains under investigation for safety and efficacy.