Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-55308942 · 3 trials · 2 indications
Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.
\[18F\]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at Tmax of JNJ-55308942 will be measured using PET scans obtained at pre and post treatment with \[18F\]-JNJ-64413739, to determine the receptor occupancy.
\[18F\]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at 24 hours postdose will be measured using PET scans obtained at pre and post treatment with \[18F\]-JNJ-64413739, to determine the receptor occupancy.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.
AUC (0-last) is defined as area under the plasma JNJ-53308942 concentration-time curve from time 0 to time of the last observed quantifiable concentration.
AUC (0-infinity) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to infinite time.
AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
The elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.
The elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
The elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
| Arm | Type | Description |
|---|---|---|
| JNJ-55308942 | EXPERIMENTAL | Participants will receive a JNJ-55308942 capsule once daily for 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a matching placebo capsule once daily for 6 weeks. |
| Part 1: JNJ-55308942 and [18F]-JNJ-64413739 | EXPERIMENTAL | Participants will first undergo a baseline positron emission tomography (PET)/ magnetic resonance (MR) scan with \[18F\]-JNJ-64413739 on Day 1. In Period 1 (on Day 2) and Period 2 (on Day 1), participants will receive oral dose of JNJ-55308942 (maximum dose 120 milligram \[mg\]). After approximately 4 hours of JNJ-55308942 dosing, participants will receive an intravenous (IV) injection of \[18F\]-JNJ-64413739, followed by a PET/MR scan. Doses will be selected based on the principal investigator's discretion. A wash-out period of at least 7 days will be maintained between the 2 doses of JNJ-55308942. |
| Part 2: JNJ-55308942 and [18F]-JNJ-64413739 | EXPERIMENTAL | Participants will first undergo a baseline PET/MR scan with \[18F\]-JNJ-64413739 on Day 1. Participants will receive oral dose of JNJ-55308942 (maximum dose 120 mg) on Day 2, followed by two post-treatment scans, one obtained at Tmax (4 hours postdose) and one at 24 hours postdose. Doses will be selected based on the principal investigator's discretion. |
| Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 0.5 milligrams (mg) or matching placebo as an oral solution after an overnight fast on Day 1 of Cohort 1 after single ascending dose (SAD). |
| Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 1.5 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 4 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part)) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 12 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 36 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 100 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 7: JNJ-55308942 or Placebo (SAD Part) | EXPERIMENTAL | Participants will be randomized to receive a single dose of JNJ-55308942 or matching placebo as an oral solution in a fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts. |
| Cohort 1: JNJ-55308942 or Placebo (MAD Part) | EXPERIMENTAL | Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the multiple ascending doses (MAD) will be determined based on the data from the SAD part. |
| Cohort 2: JNJ-55308942 or Placebo (MAD Part) | EXPERIMENTAL | Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. |
| Cohort 3: JNJ-55308942 or Placebo (MAD Part) | EXPERIMENTAL | Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. |
| Name | Type | Description |
|---|---|---|
| JNJ-55308942 | DRUG | JNJ-55308942 capsules will be administered orally. |
| Placebo | DRUG | Matching placebo capsules will be administered orally. |
| [18F]-JNJ-64413739 | DRUG | \[18F\]-JNJ-64413739 fluid for injection administered intravenously. |
| JNJ-55308942 0.5 mg | DRUG | Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1. |
| JNJ-55308942 1.5 mg | DRUG | Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1. |
| JNJ-55308942 4 mg | DRUG | Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1. |
| JNJ-55308942 12 mg | DRUG | Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1. |
| JNJ-55308942 36 mg | DRUG | Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1. |
| JNJ-55308942 100 mg | DRUG | Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1. |
| JNJ-55308942: Fed State | DRUG | Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts. |
| JNJ-55308942: MAD Part | DRUG | Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. |
Inclusion Criteria: * Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI) * Medically stable on the b...
JNJ-55308942 is an investigational small molecule being studied for the treatment of bipolar depression. It has been evaluated in a Phase 2 clinical trial in patients with bipolar disorder, as well as in Phase 1 studies in healthy volunteers to assess safety, tolerability, and pharmacokinetics.
JNJ-55308942 is a small molecule that targets the P2X7 receptor, as demonstrated in a positron emission tomography (PET) study using [18F]-JNJ-64413739 to measure receptor occupancy. The exact mechanism by which it may treat bipolar depression is not fully described in the available data.
JNJ-55308942 is being developed by Johnson & Johnson, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with bipolar disorder.
JNJ-55308942 is in Phase 2 clinical development. It has completed a Phase 2 study in bipolar depression, along with two completed Phase 1 studies in healthy participants. The drug is investigational and has not been approved by regulatory authorities.
JNJ-55308942 has been studied in three completed clinical trials: NCT03151486, a Phase 1 safety and pharmacokinetics study in healthy adults; NCT03437590, a Phase 1 PET study measuring P2X7 receptor occupancy in healthy males; and NCT05328297, a Phase 2 study in patients with bipolar depression.
No, JNJ-55308942 is not the same as JNJ-64413739. JNJ-64413739 is a radiotracer used in a PET study to measure P2X7 receptor occupancy by JNJ-55308942. The two compounds serve different purposes in clinical research.