An Open-label, Randomized Study in Healthy Participants to Investigate Effects of Food (high-fat) and Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-67953964.
- Conditions
- Major Depressive Disorder10027946
- Registration Number
- NL-OMON49179
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Healthy male and female participants between 18 and 55 years of age,
inclusive.
2. Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 inclusive
(BMI=weight/height2)
3. Participant must be healthy on the basis of clinical laboratory tests
performed at screening (e.g. serum chemistry panel, hematology, and urinalysis)
.
4. Participant must be healthy on the basis of physical examination, medical
history, vital signs, and 12-lead ECG [QTcF <= 450 msec for males and <= 470 msec
for females] performed at screening and admission to the clinical unit. Minor
abnormalities in ECG, which are not considered to be of clinical significance
by the investigator, are acceptable.
5. Non-smokers (not smoked for 3 months prior to screening).
1. History of or current significant medical illness including (but not limited
to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid
abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or
hepatic insufficiency, thyroid disease, Parkinson*s disease, infection, or any
other illness that the Investigator considers should exclude the participant.
2. History of any gastric surgery, documented gastric disease (including peptic
ulcer disease, gastritis, achlorhydria, upper GI bleeding, esophagitis, or any
GI precancerous condition), current clinically evident GI complaints including
functional gastrointestinal disorders (FGID).
3. Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus
(HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
4. Participant has a history of at least mild drug or alcohol use disorder
according to Diagnostic and Statistical Manual of Mental Disorders (5th
edition) (DSM-V) criteria within 6 months before Screening or positive test
result(s) for alcohol, nicotine metabolites and/or drugs of abuse (opiates
[including methadone], cocaine, amphetamines, methamphetamines, cannabinoids,
barbiturates, ecstasy and benzodiazepines) at screening or admission.
5. 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, which is considered cured with minimal risk of
recurrence).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the assessment of the PK of JNJ-67953964 under<br /><br>different conditions. These include but are not limited to:<br /><br>- Cmax - peak plasma concentration<br /><br>- tmax - time to reach the Cmax<br /><br>- AUClast area- under the plasma concentration-time curve from 0 to t hours<br /><br>postdosing,calculated by trapezoidal summation (time t is the time of the last<br /><br>quantifiable concentration Clast)<br /><br>- AUC* - AUCt extrapolated to infinity, calculated as AUCt + Clast/ *z<br /><br>- *z - elimination rate constant, determined by linear regression of the<br /><br>terminal points of the ln-linear plasma concentration-time curve<br /><br>- t* terminal half-life, defined as 0.693/*z<br /><br>Geometric mean ratio of the AUCs and Cmax in fed vs fasted conditions and in<br /><br>the presence vs. absence of itraconazole.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Main secondary endpoints include:<br /><br>- AEs and AEs of interest<br /><br>- Changes in vital signs and ECG<br /><br>- Changes in clinical laboratory parameters<br /><br>- Concentration of JNJ-67953964 metabolites in plasma and urine<br /><br>- Concentration of JNJ-67953964 in urine.</p><br>