An open-label, fixed-sequence study in healthy male subjects to assess the effect of single and multiple-doses of JNJ-54861911 on the components of a Drug *Cocktail* representative for CYP3A4, CYP2C9, and CYP1A2 substrates.
- Conditions
- ervous System Diseases - nervous system disorder (Alzheimer's disease)Early Alzheimer's Disease
- Registration Number
- NL-OMON41185
- Lead Sponsor
- QPS Netherlands B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phamacokinetics<br /><br>Safety<br /><br>Tolerability</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A.</p><br>