Study to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076 in Healthy Participants
Status: | Withdrawn |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 12/22/2017 |
Start Date: | November 22, 2016 |
End Date: | February 17, 2017 |
An Exploratory Open-Label, Single Dose, Randomized, Three-Way Crossover Study In Healthy Subjects to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials