anxiety mood disorders and substance abuse panic
Conditions
Interventions
JNJ-61393215 or placebo
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have a body mass index (BMI) between 18 and 30 kg/m2, inclusive (BMI = weight/height2). 2. Subject must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [incl. QTcF
Exclusion criteria
Exclusion criteria: 1. Subject has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness. Minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable. 2. Subject has estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 at screening (provided by the local laboratory). 3. Subject has a heart rate < 50 bpm at screening or at admission to the clinical unit. 4. Subject has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening. 5. Subject has Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD]. 6. Subject has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening. 7. Subject has a 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 that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence). 8. Subject has a history of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (latest edition) criteria within 6 months before screening or has a positive test result(s) for alcohol and/or drugs of abuse (including: opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening or admission to the clinical unit. 9. Subject drinks, on average, more than 8 cups of tea/coffee/cocoa/cola/caffeinated beverages (e.g., energy drink) per day. 10. Subject has a clinically significant acute illness within 7 days prior to study drug administration. 11. Subject smokes cigarettes (or equivalent) and/or has used nicotine based products within 3 months prior to study drug administration. 12. Subject is a man who plans to father a child while enrolled in this study or within 90 days after the last dose of study drug. 13. Subject has a history of clinically significant drug and/or food allergies. 14. Subject has known allergies, hypersensitivity, or intolerance to orexin-1*s excipients (refer to Investigator's Brochure). 15. Subject has taken any disallowed therapies before the planned first dose of study drug, as noted in Section 8, Prestudy and Concomitant Therapy. 16. Subject has received an investigational drug (including vaccines) or used an investigational medical device within 90 days prior to study drug administration or is currently enrolled in an investigational study. 17. Subject has had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Adverse events - Clinical laboratory tests - ECG - Telemetry - Vital signs - Physical & neurological examination Pharmacokinetic parameters Cmax, Clast, Tmax, Tlast, AUClast, Lambda, T1/2, CL/F, CLCR | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameters Cortisol & prolactin Biomarkers | — |
Countries
Netherlands
Outcome results
None listed