A phase 1, open-label, randomized, 2-way crossover study to assess the effects of acid reducing agent(s) on the pharmacokinetics of a single oral dose of JNJ-64417184 in healthy adult participants
- Conditions
- Respiratory syncytial virus10024970
- Registration Number
- NL-OMON50152
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
1. Male or female, 18 to 54 years of age, extremes included, at screening.
2. Must have a body mass index between 18.0 and 30.0 kg/m2, extremes included,
and body weight not less than 50.0 kg at screening.
3. Healthy on the basis of physical examination, medical and surgical history,
and vital signs performed at screening. If there are abnormalities other than
those listed in Exclusion Criteria 2 and 3, the participant 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 participant's source documents and
initialed by the investigator.
4. Must have a normal 12-lead ECG (triplicate) at screening, including: normal
sinus rhythm (heart rate between 45 and 100 beats per minute, extremes
included); QT interval corrected for heart rate (QTc) according to Fridericia
(QTcF) <=450 ms for male participants and <=470 ms for female participants; QRS
interval <120 ms; PR interval <=200 ms. If the results of the ECG are outside
the normal ranges, the participant may be included only if the investigator
judges the deviations from normal ECG to be not clinically significant or to be
appropriate and reasonable for the population under study. This determination
must be recorded in the participant's source documents and initialed by the
investigator.
5. Must not use nicotine-containing substances including tobacco products (eg,
cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least
3 months prior to screening.
For additional inclusion criteria, cross-refer to the protocol
1. 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] formula),
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.
2. Past history of clinically significant cardiac arrhythmias (eg,
extrasystoli, tachycardia at rest), history of risk factors for Torsade de
Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome).
3. Any evidence of clinically significant heart block or bundle branch block at
screening.
4. Current human immunodeficiency virus 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.
For additional exclusion criteria cross-refer to the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To evaluate the effect of multiple-dose administration of lansoprazole on the<br /><br>single-dose PK of JNJ-64417184 in healthy adult participants<br /><br>- To evaluate the effect of time-separated, multiple-dose administration of<br /><br>famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants<br /><br>(optional).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To explore the safety and tolerability of single-dose JNJ-64417184 when<br /><br>administered alone and in combination with multiple-dose lansoprazole or<br /><br>famotidine (optional) in healthy adult participants.</p><br>