low mood Mood disorders
Conditions
Interventions
JNJ-69095897 or placebo, subsequent dose levels are to be determined following
satisfactory review of the safety, tolerability, pharmacodynamic and
pharmacokinetic data from previous cohorts.
Sponsors
Janssen Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part 1 and 2: Males with a minimum age of 18 years and maximum age 55 years inclusive, Part 3: males or female (women of non childbearing potential) with a minimum age of 35 years and a maximum age of 75 years inclusive, -Healthy based on physical examination, medical history, vital signs, and 12-lead ECG (means of triplicate ECG, incl. QT corrected according to Fridericia's formula (QTcF)
Exclusion criteria
Exclusion criteria: 1. Has a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, orthostatic hypotension, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. or any other illness that the investigator considers should exclude the participant. 2. Has a diagnosis or suspicions of any sleep disorder in the last 6 months or current complaints of sleep disturbance, irregular sleep schedule or shift work; habitual daytime naps; travel across time zones in the last 4 weeks or daytime symptoms attributable to unsatisfactory sleep. 3. Has a history of or current major or clinically relevant psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) (e.g., mood, anxiety disorders, psychotic disorder etc.). 4. Has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the C-SSRS at screening or baseline. Participants with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator. 5. Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients. 6. Has a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within three minutes of standing compared with blood pressure from the supine position, during orthostatic blood pressure measurements at screening or baseline. 7. Has 3-second or more pauses in 12-lead ECG Holter based on 24 hours Holter monitoring conducted at screening 8. Has a personal or family history of recurrent (exertional) syncope or presyncope. 9. Has previously experienced vasovagal syncope's.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Vital signs (heart/pulse rate, systolic blood Pressure, diastolic blood pressure, tympanic body temperature), respiratory rate, clinical labs (chemistry, hematology, urinalysis, coagulation [Part 3 only]), adverse events (AE), electrocardiogram (ECG) and Holter recordings. 2. Blood, plasma, CSF, and urine concentrations of JNJ-69095897 and possible metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma 2-AG levels. 2. Plasma, blood and urine concentrations of JNJ-69095897 and possible metabolites. 3. Plasma and CSF 2-AG levels. | — |
Countries
Netherlands
Outcome results
None listed