A phase 1, 4-period, crossover, open-label study in healthy volunteers to assess the effect of different types of food on a single-dose of JNJ-64417184 administered as tablets.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Male or female, 18 to 55 years of age, extremes included, at screening.
2. During the study (from the day of first study drug intake onwards) and for a
minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after the
last study drug intake, a male subject must agree:
• To wear a condom when engaging in any activity that allows for passage of
ejaculate to another person (male subject should also be advised of the benefit
for a female partner to use a highly effective method of contraception as
condom may break or leak);
• Not to donate sperm for the purpose of reproduction.
Contraceptive use should be consistent with local regulations regarding the use
of contraceptive methods for subjects participating in clinical studies.
3. Female subjects must be of non-childbearing potential defined as:
• Postmenopausal
A postmenopausal state is defined as no menses for >12 months without an
alternative medical explanation. A high follicle stimulating hormone (FSH)
level (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a
postmenopausal state in women not using hormonal contraception or hormone
replacement therapy. In the absence of >12 months of amenorrhea, 2 FSH
measurements have to be available, measured at least 3 months apart, OR
• Permanently sterile
Permanent sterilization methods include hysterectomy, bilateral salpingectomy,
bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.
4. Must have a body mass index (BMI; weight [kg]/height2 [m2]) between 18.0 and
30.0 kg/m2, extremes included, and body weight not less than 50.0 kg at
screening.
5. Healthy on the basis of physical examination, medical and surgical history,
and vital signs performed at screening. If there are abnormalities, the subject
may be included only if the investigator judges the abnormalities to be not
clinically significant or to be appropriate and reasonable for the population
under study. This determination must be recorded in the subject's source
documents and initialed by the investigator.
Further Criteria apply.

Exclusion Criteria

1. Any evidence of heart block or bundle branch block at screening.
2. History of liver or renal dysfunction (calculated creatinine
clearance/estimated glomerular filtration rate (eGFR) <60 mL/min at screening,
calculated by the Modification of Diet in Renal Disease [MDRD] formula28),
significant cardiac, vascular, pulmonary, gastrointestinal (such as significant
diarrhea, gastric stasis, or constipation that in the investigator*s opinion
could influence drug absorption or bioavailability), endocrine, neurologic,
hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
3. Past history of cardiac arrhythmias (eg, extrasystoli, tachycardia at rest),
history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia,
family history of long QT Syndrome).
4. Current HIV-type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at
screening.
5. History of hepatitis A, B, or C infection, or current hepatitis A infection
(confirmed by hepatitis A antibody immunoglobulin M [IgM]), or HBV infection
(confirmed by hepatitis B surface antigen), or HCV infection (confirmed by HCV
antibody) at screening.
Further criteria apply.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To evaluate the effect of 45 different types of food conditions on the single<br /><br>dose PK of the JNJ184JNJ-64417184 tablet formulation administered orally, using<br /><br>the PK after a high fat meal as a reference, in healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To determine the PK parameters of JNJ-64417184 after a single dose.<br /><br>• To assess the safety and tolerability of JNJ-64417184 after a single dose<br /><br>when administered to healthy adult subjects.</p><br>