Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-61393215 · 6 trials · 2 indications
Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Plasma samples will be analyzed to determine concentrations of JNJ-61393215 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
Cmax is defined as the maximum observed analyte concentration.
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
AUC(0-last) is defined as the area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification level \[non-BQL\]) analyte concentration calculated by linear-linear trapezoidal summation.
AUC (0-infinity) is defined as the area under the analyte concentration vs. time curve from time 0 to infinite time, calculated as AUC(0-last) + Clast/lambda(z), where Clast is the last observed measurable (non-BQL) analyte concentration.
lambda(z) is estimated by linear regression using the terminal logarithmic (log)-linear phase of the log transformed concentration vs time data.
T1/2 is defined as the apparent terminal elimination half-life and is calculated as 0.693/lambda(z).
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired analyte concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Cmax is defined as the maximum observed analyte concentration.
AUC(0-last) is defined as the area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification level \[non-BQL\]) analyte concentration calculated by linear-linear trapezoidal summation.
AUC(0-infinity) is defined as the area under the analyte concentration vs. time curve from time 0 to infinite time, calculated as AUC(0-last) + Clast/lambda(z), where Clast is the last observed measurable (non-BQL) analyte concentration.
Cmax is defined as the maximum observed analyte concentration.
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area under the analyte concentration vs time curve from time 0 to 24 hours, calculated by linear-linear trapezoidal summation.
Ctrough is defined as the observed analyte concentration just prior to the beginning or at the end of a dosing interval. Ctrough estimation does not include the concentration that occurs just prior to the first dose.
Cmin is defined as the minimum observed analyte concentration during the dosing interval.
Cavg is defined as the value of the average analyte concentration at steady state over the dosing interval.
FI is estimated as the percentage fluctuation (variation) between the maximum and minimum analyte concentration at steady state.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\[0-infinity\])\*(AUMC\[0-infinity\])/AUC\[0-infinity\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
lambda(z) is estimated by linear regression using the terminal logarithmic (log)-linear phase of the log transformed concentration vs time data.
T1/2 is defined as the apparent terminal elimination half-life and is calculated as 0.693/lambda(z).
Peak by trough ratio is defined as the ratio of the maximum observed analyte concentration to the minimum observed analyte concentration.
AR AUC is determined after multiple-dose administration and calculated as AUC (0-24h) on day 7 divided by AUC (0-24h) on day 1.
ARCmax is determined after multiple-dose administration and calculated as Cmax on day 7 divided by Cmax on day 1.
Cmax is the maximum observed plasma concentration.
Clast is the last quantifiable Plasma concentration.
Tmax is the time to reach maximum plasma concentration.
Tlast is the time to last observed quantifiable plasma concentration.
AUClast is the area under the plasma concentration-time curve from time zero to last quantifiable time.
AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Tmax is time to reach the maximum plasma concentration.
Cmax is maximum plasma concentration.
AUC\[0-24\] is area under the plasma concentration- time curve from time \[0 to 24\].
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Cmin is minimum observed plasma concentration during dosing interval (tau).
Cavg is average plasma concentration at steady state over the dosing interval.
Fluctuation Index is defined as percentage of fluctuation, calculated as: 100\*(\[Cmax-Cmin\]/Cavg).
CL/F is total apparent oral clearance, calculated as dose/AUCtau at steady-state.
Lambda\[Z\] is apparent terminal elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
T1/2term is apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, after multiple-dose administration only.
Ratio Cmax,test/ref is ratio of maximum plasma concentration (Cmax) test (day 7 \[steady-state\]/ref (day 1).
Ratio AUC24h,test/ref is ratio of area under the plasma concentration- time curve from time \[0 to 24\] (AUC\[0-24\]) test (day 7 \[steady-state\]/ref (day 1).
The Cmax is the maximum observed plasma concentration.
The Clast is the last quantifiable plasma concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The Tlast is defined as the time of the last quantifiable plasma concentration.
The (AUC \[0-last\]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as: D/AUC infinity.
| Arm | Type | Description |
|---|---|---|
| JNJ-61393215 135 milligram (mg) | EXPERIMENTAL | Participants will receive JNJ-61393215 135 mg (3\*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
| JNJ-61393215 | EXPERIMENTAL | Participants will receive one of 3 single oral doses of JNJ-61393215 on Day 1, escalated sequentially based on the safety review in Cohorts 1, 2, and 3 up to Day 5. |
| Part 1 (Single Ascending Dose [SAD]): Cohort 1 | EXPERIMENTAL | Participants will receive single oral dose of JNJ-61393215 145 milligram (mg) suspension or matching placebo on day 1, under fasted conditions. |
| Part 1 SAD: Cohort 2 | EXPERIMENTAL | Participants will receive single oral dose of JNJ-61393215 225 mg suspension or matching placebo on day 1 under fasted conditions. Dose in this cohort will be determined based on safety and PK data of cohort 1. |
| Part 2 Cohort 3: Treatment Sequence CDEF | EXPERIMENTAL | Participants will receive single oral dose of JNJ-61393215 30 mg suspension under fasted condition (Treatment C) in Period 1, then participants will receive single oral dose of JNJ-61393215 30 mg capsule under fasted condition (Treatment D) in Period 2, single oral dose of JNJ-61393215 30 mg capsule with high fat/high-calorie breakfast (Treatment E) in Period 3 followed by single oral dose of JNJ-61393215 30 mg capsule with standardized breakfast (Treatment F) in Period 4, on day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods. |
| Part 2 Cohort 3: Treatment Sequence DFCE | EXPERIMENTAL | Participants will receive Treatment D in Period 1, then Treatment F in Period 2, then Treatment C in Period 3 followed by Treatment E in Period 4 on Day 1. |
| Part 2 Cohort 3: Treatment Sequence ECFD | EXPERIMENTAL | Participants will receive Treatment E in Period 1, then Treatment C in Period 2, then Treatment F in Period 3 followed by Treatment D in Period 4 on Day 1. |
| Part 2 Cohort 3: Treatment Sequence FEDC | EXPERIMENTAL | Participants will receive Treatment F in Period 1, then Treatment E in Period 2, then Treatment D in Period 3 followed by Treatment C in Period 4 on Day 1. |
| Part 2 Cohort 4: Treatment Sequence GHIJ | EXPERIMENTAL | Participants will receive single oral dose of JNJ-61393215 suspension under fasted condition (Treatment G) in Period 1, then participants will receive single oral dose of JNJ-61393215 capsule under fasted condition (Treatment H) in Period 2, single oral dose of JNJ-61393215 capsule with high fat/high-calorie breakfast (Treatment I) in Period 3 followed by single oral dose of JNJ-61393215 capsule with standardized breakfast (Treatment J) in Period 4, on day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods. Dose in this cohort will be based on the results obtained in Part 1. |
| Part 2 Cohort 4: Treatment Sequence HJGI | EXPERIMENTAL | Participants will receive Treatment H in Period 1, then Treatment J in Period 2, then Treatment D in Period G followed by Treatment I in Period 4 on Day 1. |
| Part 2 Cohort 4: Treatment Sequence IGJH | EXPERIMENTAL | Participants will receive Treatment I in Period 1, then Treatment G in Period 2, then Treatment J in Period 3 followed by Treatment H in Period 4 on Day 1. |
| Part 2 Cohort 4: Treatment Sequence JIHG | EXPERIMENTAL | Participants will receive Treatment J in Period 1, then Treatment I in Period 2, then Treatment H in Period 3 followed by Treatment G in Period 4 on Day 1. |
| Part 3 Cohort 5: Multiple Ascending Dose | EXPERIMENTAL | Participants will receive oral JNJ-61393215 145 mg suspension or matching placebo once daily for 7 days under fasted conditions. |
| Part 3 Cohort 6: Multiple Ascending Dose | EXPERIMENTAL | Participants will receive oral JNJ-61393215 225 mg suspension or matching placebo once daily for 7 days under fasted conditions. Dose may be lowered or increased based on the evaluation of safety and PK of Cohort 5. This dose may be the same as the dose chosen for Cohort 2 (Part 1), or it could be different. |
| JNJ-61393215 2 mg + Ritonavir 100 mg | EXPERIMENTAL | Participants will receive suspension of JNJ-61393215 2 mg (Day 1 and 5) orally and tablet of Ritonavir 100 mg twice a Day (Day 4-14) orally. |
| JNJ-61393215 (Multiple Ascending Dose Phase) | EXPERIMENTAL | Participants will receive JNJ- 61393215 once daily for 7 days. 4 sequential cohorts will be enrolled to evaluate escalating doses which will be defined, based on safety, tolerability and pharmacokinetic (PK) data from the preceding cohorts. Dose adjustment/selection (increase/decrease) for the next cohort will be based on the JNJ- 61393215 PK profile up to and including the last day of dosing (24 hours postdose) and the safety and tolerability profile of the current cohort. |
| Placebo (Multiple Ascending Dose Phase) | PLACEBO_COMPARATOR | Participants will receive JNJ- 61393215 matching placebo for 7 days. |
| Part 1: Cohort 1 | EXPERIMENTAL | Participants will receive 1 milligram (mg) JNJ-61393215 or placebo. |
| Part 1: Cohort 2 | EXPERIMENTAL | Participants will receive 5 mg JNJ-61393215 or placebo. |
| Part 1: Cohort 3 | EXPERIMENTAL | Participants will receive 15 mg JNJ-61393215 or placebo. |
| Part 1: Cohort 4 | EXPERIMENTAL | Participants will receive 30 mg JNJ-61393215 or placebo. |
| Part 1: Cohort 5 | EXPERIMENTAL | Participants will receive 45 mg JNJ-61393215 or placebo. |
| Part 1: Cohort 6 | EXPERIMENTAL | Participants will receive 60 mg JNJ-61393215 or placebo. |
| Part 1: Cohort 7 | EXPERIMENTAL | Participants will receive 90 mg JNJ-61393215 or placebo. |
| Part 1: Cohort 8 | EXPERIMENTAL | Participants will receive 120 mg JNJ-61393215 or placebo. |
| Part 2 | EXPERIMENTAL | Participants will receive JNJ-61393215 (dose to be determined). |
| Part 3 | EXPERIMENTAL | Participants will receive JNJ-61393125 (dose to be determined) or placebo under fed conditions. |
| Name | Type | Description |
|---|---|---|
| JNJ-61393215 | DRUG | JNJ-61393215 will be administrated orally. |
| Placebo | DRUG | Matching placebo will be administered orally. |
| Ritonavir | DRUG | Participants will receive 100 mg of ritonavir tablet orally. |
Inclusion Criteria: * Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m\^2) * Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress...
JNJ-61393215 is an investigational small molecule being studied for use in healthy participants and in Major Depressive Disorder with Anxious Distress. It is currently in Phase 1 clinical development and is not approved by the FDA.
JNJ-61393215 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company has completed five Phase 1 clinical trials for this investigational drug.
JNJ-61393215 is in Phase 1 clinical development. All five of its clinical trials have been completed, with a total enrollment of 244 participants. It remains an investigational drug and has not received FDA approval.
JNJ-61393215 has completed five Phase 1 trials, including NCT02812251, NCT03007693, NCT03593954, and NCT03649997. These trials studied safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants, with one trial assessing the effect of ritonavir on the drug.
Yes, JNJ-61393215 is the same drug as JNJ 61393215. The name appears in clinical trial records with and without a hyphen, but both refer to the same investigational small molecule being developed by Johnson & Johnson.