- To assess the effects of single and multiple daily doses of 50 mg JNJ-54861911 once daily (q.d.) on the pharmacokinetics of caffeine, midazolam, and tolbutamide in healthy male subjects. - To assess the safety and tolerability of the concomitant…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Nervous System Diseases - nervous system disorder (Alzheimer's disease)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phamacokinetics
Safety
Tolerability
Secondary outcome
N.A.
Background summary
The purpose of this study is to find out what effect JNJ-54861911 has on the
combination of caffeine, midazolam and tolbutamide. Another purpose is to find
out if JNJ-54861911 can cause side effects (unexpected or unwanted reactions
from taking a drug) when it is given together with caffeine, midazolam and
tolbutamide.
Study objective
- To assess the effects of single and multiple daily doses of 50 mg
JNJ-54861911
once daily (q.d.) on the pharmacokinetics of caffeine, midazolam, and
tolbutamide in healthy male subjects.
- To assess the safety and tolerability of the concomitant use of
JNJ-54861911
q.d. with caffeine, midazolam, and tolbutamide.
Study design
This is 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.
Intervention
- 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
- Urine sampling
- Alcohol breath test
- Monitoring for hypoglycemia
- Blood draw: needle or a cannula, a total of about 306 mL will be drawn during
the entire study
- Questions regardiing general health.
Study burden and risks
The risk is small. The patients will be closely monitored. The patients will be
regularly questioned for any side effects and safety tests are scheduled (vital
signs). The patients will be asked to report, as soon aspossible, any changes
in physical and/or mental well being.
The blood collection procedure is not dangerous, but may cause discomfort or
bruising. Occasionally, fainting or an infection at the blood sampling site may
occur.
Shaving may be required for proper placemant of ECGpatches. This may cause
irritation or bleeding of the skin.
ECG patches may cause redness, itching, rash, or blisters on the skin and/or
hair loss due to removal of ECG patches.
Petrus Campussingel 123
Groningen 9713 AG
NL
Petrus Campussingel 123
Groningen 9713 AG
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001794-14-NL |
| CCMO | NL50154.056.14 |