Clinical trial NCT04453189: A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-07-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to evaluate the effect of multiple-dose administration of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult participants; and to evaluate the effect of time-separated, multiple-dose administration of famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).


Eligibility criteria: Inclusion Criteria:

* Must have a body mass index (BMI) between 18.0 and 30.0 kilograms per square meters \[kg/m\^2\]), extremes included, and body weight not less than 50.0 kilograms (kg) at screening
* Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening
* Must have a normal 12-lead Electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF) less than or equal to (\<=) 450 milliseconds (ms) for male participants and \<= 470 ms for female participants; QRS interval less than (\<) 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
* Must sign an informed consent form (ICF) indicating he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

* History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) \<60 milliliter per minute (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
* Past history of clinically significant cardiac arrhythmias (for example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
* Any evidence of clinically significant heart block or bundle branch block at screening
* Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
* History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by hepatitis C virus \[HCV\] antibody) at screening

Primary outcomes:
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)
measure: Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-last]) of JNJ-64417184
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)
measure: Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-64417184
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)
Secondary outcomes:
measure: Number of Participants with Adverse Event as a Measure of Safety and Tolerability
timeFrame: Up to 2.5 months
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to 2.5 years
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to 2.5 years
measure: Number of Participants with Clinically Significant Abnormalities in Electrocardiogram
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: