depression
Conditions
Interventions
Participants will receive JNJ-54175446/placebo (7 of 10 subjects) once a day
for 11 consecutive days, or Minocycline/placebo (3 of 10 subject) twice a day
for 11 consecutive days. On Day -5 subjects
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects between 18 and 55 years of age, inclusive. 2. A body mass index (BMI) between 18 and 32 kg/m2, inclusive 3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [incl. QTcF
Exclusion criteria
Exclusion criteria: 1. A history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the subject. 2. A clinically significant (history of) psychiatric illnesses or (history of) psychotic symptoms 3. A family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree) 4. A liver function test (including ALT, AST, GGT, ALP and bilirubin) at screening exceeding the ULN. 5. 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. 6. A history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening. 7. A PT and/or an aPTT exceeding the ULN. 8 An International Normalized Ratio (INR; [prothrombintest / prothrombincontrol]ISI) >2. 9. A history of malignancy within 5 years before screening (with certain exceptions) 10. A history of drug or alcohol use disorder (mild or greater) according to DSM criteria within 5 years before Screening. Or a positive test result(s) for alcohol and/or drugs of abuse (including: opiates (including methadone), cocaine, amphetamines (screening only) and methamphetamines (screening only), MDMA (screening only), cannabinoids, and benzodiazepines) at screening or admission to the clinical unit. 11. Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola/caffeinated beverages (e.g., energy drink) per day. 12. A clinically significant acute illness within 7 days prior to study drug administration. 13. Smokes cigarettes (or equivalent) and/or has used nicotine based products within 3 months prior to study drug administration. 14. A man who plans to father a child while enrolled in this study or within 90 days after the last dose of study drug. 15. A history of clinically significant drug and/or food allergies. 16. Known allergies, hypersensitivity, or intolerance to JNJ-54175446, AMPH or minocycline or one of their excipients. 17. Contraindications to the use of minocycline or AMPH. 18. Taken any disallowed therapies (protocol Section 8) 19. Received an investigational drug (including vaccines) or used an IMD within 90 days before the planned start of study. 20. Had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will have within 4 weeks after the last dose. 21. Donated one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration 22. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 23. Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements. 24. Vulnerable subjects (e.g., a person kept in detention or a person under guardianship). 25. Unable to read and understand the consent forms, complete study-related procedures, and/or communicate with the study staff. 26. An employee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK PD Safety Tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| ex vivo-stimulated cytokine production P2X7 receptor polymorphism | — |
Countries
Netherlands
Outcome results
None listed