A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 2/17/2017 |
Start Date: | October 2016 |
End Date: | December 2016 |
A Randomized, Open-label, 2-Way Crossover, Parallel-group Study in Healthy Male and Female Subjects to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446
The primary purpose of the study is to investigate the plasma pharmacokinetics and
bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths
of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of
JNJ-54175446 under fasting conditions.
bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths
of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of
JNJ-54175446 under fasting conditions.
Inclusion Criteria:
- A body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m^2),
inclusive (BMI = weight/height^2)
- Healthy on the basis of physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) [inclusive QTcF less than or equal to (<=) 450
millisecond (msec) for males and <= 470 msec for females] performed at screening and
admission (Treatment period 1) to the clinical unit. Minor abnormalities in ECG,
which are not considered to be of clinical significance by the physician
investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB),
atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or
implantable cardioverter defibrillator [ICD] will lead to exclusion
- Healthy on the basis of clinical laboratory tests performed at Screening. If the
results of the serum chemistry panel [excluding liver function tests], hematology
[including coagulation], or urinalysis are outside the normal reference ranges, the
participant may be included only if the investigator judges the abnormalities to be
not clinically significant. This determination must be recorded in the participant's
source documents and initialed/signed by the physician investigator
- Must be willing to adhere to the prohibitions and restrictions specified in this
protocol
- Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of and procedures required for the study and are willing to participate in
the study
Exclusion Criteria:
- History of or current liver or renal insufficiency (estimated creatinine clearance
below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic (including coagulation
disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory
illness or any other illness that the Investigator considers should exclude the
participant
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
positive, or other clinically active liver disease, or tests positive for HBsAg or
anti-HCV at Screening
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive
for HIV at Screening
- 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
that, in the opinion of the investigator, with written concurrence with the sponsor's
medical monitor, is considered cured with minimal risk of recurrence)
- History of at least mild drug or alcohol use disorder according to Diagnostic and
Statistical Manual of Mental Disorders (latest edition DSM-5) criteria within 6
months before Screening
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