Major Depressive Disorder
Conditions
Interventions
JNJ-67953964 will be given as 2 capsules of 5 mg for a total of 10 mg JNJ
67953964. The capsules will be ingested with 240 milliliters (mL) of water. In
Period 1 and 2 all volunteers will receive th
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants between 18 and 55 years of age, inclusive. 2. Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 inclusive (BMI=weight/height2) 3. Participant must be healthy on the basis of clinical laboratory tests performed at screening (e.g. serum chemistry panel, hematology, and urinalysis) . 4. Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [QTcF
Exclusion criteria
Exclusion criteria: 1. History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson*s disease, infection, or any other illness that the Investigator considers should exclude the participant. 2. History of any gastric surgery, documented gastric disease (including peptic ulcer disease, gastritis, achlorhydria, upper GI bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints including functional gastrointestinal disorders (FGID). 3. Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies. 4. Participant has a history of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before Screening or positive test result(s) for alcohol, nicotine metabolites and/or drugs of abuse (opiates [including methadone], cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission. 5. History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the assessment of the PK of JNJ-67953964 under different conditions. These include but are not limited to: - Cmax - peak plasma concentration - tmax - time to reach the Cmax - AUClast area- under the plasma concentration-time curve from 0 to t hours postdosing,calculated by trapezoidal summation (time t is the time of the last quantifiable concentration Clast) - AUC* - AUCt extrapolated to infinity, calculated as AUCt + Clast/ *z - *z - elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve - t* terminal half-life, defined as 0.693/*z Geometric mean ratio of the AUCs and Cmax in fed vs fasted conditions and in the presence vs. absence of itraconazole. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoints include: - AEs and AEs of interest - Changes in vital signs and ECG - Changes in clinical laboratory parameters - Concentration of JNJ-67953964 metabolites in plasma and urine - Concentration of JNJ-67953964 in urine. | — |
Countries
Netherlands
Outcome results
None listed