Nervous System Diseases - nervous system disorder (Alzheimer's disease) Early Alzheimer's Disease
Conditions
Interventions
- Review of medical history
- Review of medications
- Physical exam (including height and body weight)
- Vital signs: supine and standing blood pressure, pulse rate and oral
temperature.
- ECG
- Ur
Sponsors
QPS Netherlands B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be a man, 18 to 55 years of age, inclusive. 2. Subjects must have a body mass index (BMI) between 18 and 30 kg/m2, inclusive (BMI = weight/height²) and a body weight of not less than 50 kg. 3. Subject must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening or admission (up to Day 1 predose). Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.
Exclusion criteria
Exclusion criteria: 1. Subject has any clinically significant abnormal findings in physical examination, vital signs or 12-lead ECG (incl. QTcF>450msec, Left Bundle Branch Block, AV Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD)) at screening or admission (up to Day 1 predose), which in the opinion of the investigator are not appropriate and reasonable for the population under study. 2. Subject has a history of or current liver or renal insufficiency; closedangle glaucoma, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine (e.g. thyroid disease, diabetis mellitus), neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 3. Subject has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse. 4. Subject has a known history of glucose-6-phopshate dehydrogenase deficiency (G6PD) deficiency (favism) 5. Subject has known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients (refer to IB), sulfonamides, midazolam, caffeine or tolbutamide. 6. Subject has contraindications to the use of caffeine, midazolam or tolbutamide per local prescribing information. 7. Subject has had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phamacokinetics Safety Tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed