Healthy
Conditions
Brief summary
The purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.
Interventions
DRUGJNJ-54416076 (Oral Suspension)
Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2.
DRUGJNJ-54416076 (Formulation 1: Direct Compression Tablets)
Participants will receive JNJ-54416076 Tablet formulation 1 (5\*5 mg Tablets \[25 mg total\]) under fasted and fed condition in Part 1.
DRUGJNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)
Participants will receive JNJ-54416076 Tablet formulation 2 (5\*5 mg Tablets \[25 mg total\]) under fasted and fed condition in Part 2.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Before randomization, a woman must be: 1) Postmenopausal, defined as a) Greater than (\>) 45 years of age with amenorrhea for greater than or equal to (\>=)18 months, or b) \> 45 years of age with amenorrhea for at least 6 months and lesser than (\<)18 months and a serum follicle stimulating hormone (FSH) level \>40 International units per liter (IU/L), or 2) Surgically sterile due to a hysterectomy, or bilateral oophorectomy, or bilateral tubal occlusion/ligation procedures, and 3) All women must have a negative serum pregnancy test at Screening; and on Day -1 at each treatment period * Men (including those who have had vasectomies) must agree to use condoms even if their partner is pregnant (this is to ensure that the fetus is not exposed to the study drug through vaginal absorption) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Male participants should encourage their female partner to use an effective method (for example (eg), prescription oral contraceptives, contraceptive injections, intrauterine device, and contraceptive patch) of contraception in addition to the condom used by the male study participant * Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiograms (ECGs) performed. If any of the results are abnormal, the participant may be included only if the investigator judges that the abnormalities or deviations from normal are not clinically significant except for liver function and hematology tests. This determination must be recorded in the participant's source documents and initialed by the investigator * Body Mass Index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2)(inclusive) and body weight \>= 50 kilograms * Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive at Screening and on Days -2 and -1 of Period 1. If blood pressure is out of range, up to 2 repeated assessments are permitted
Exclusion criteria
* History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (eg, hyper/hypo-thyroidism), hematological disease (eg, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, renal disorder, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results * History of Gilbert's disease, Dubin-Johnson or Rotor syndrome, or any family history of liver or gallbladder disease that may suggest an underlying genetic disorder * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), bilirubin levels (indirect, or direct), or alkaline phosphatase above the upper limit of normal (ULN) of the clinical laboratory's reference range at Screening or at Day -1 of Period 1 * Hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the clinical laboratory's reference range at Screening. On Day -1 of Period 1, if participants have hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the laboratory's reference range, the participants may be included if the investigator judges that the abnormalities or deviations from the reference are not clinically significant * History of cholecystectomy or gallbladder disease * Known allergies, hypersensitivity, or intolerance to any of the excipients of the formulation * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Analyte Concentration (Cmax) | Predose up to Day 4 | Cmax is the maximum observed analyte concentration. |
| Time to Reach Maximum Concentration (Tmax) | Predose up to Day 4 | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. |
| Area Under Concentration Curve from time zero to the last quantifiable (AUC [0-last]) | Predose up to Day 4 | Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear trapezoidal summation. |
| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | Predose up to Day 4 | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. |
| Apparent Terminal Elimination Half-life (t1/2term) | Predose up to Day 4 | The elimination halflife (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda\[z\]). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 5 to 7 days after discharge (Follow-Up Phase ) |
Countries
United States
Outcome results
None listed