Clinical trial NCT04258189: A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants
Official title: A Phase 1, Randomized, Open-label, 4-Period Crossover Study in Healthy Subjects to Assess the Food Effect on a Single Dose of JNJ-64417184 Administered as an Oral Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 16
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 purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Must have a body mass index (BMI; weight \[kg\]/height\^2 \[m\^2\]) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg at screening
* Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, 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
* Healthy on the basis of clinical laboratory tests performed at screening
* Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening
* Female participant must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria:

* History of liver or renal dysfunction 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 cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Any evidence of 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
* A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

Primary outcomes:
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
timeFrame: Up to Day 6
measure: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-64417184
timeFrame: Up to Day 6
measure: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184
timeFrame: Up to Day 6
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 28 days
measure: Acceptability of the JNJ-64417184 Formulation as Assessed by Participant
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: