A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: JNJ-64417184
- Registration Number
- NCT04258189
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Panel 1: Treatment Sequence CDBA JNJ-64417184 Participants will receive Treatment C in treatment Period 1; followed by Treatment D in treatment Period 2; followed by Treatment B in treatment Period 3, followed by Treatment A in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Optional Panel 2: Treatment Sequence FGE JNJ-64417184 Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Optional Panel 2: Treatment Sequence EFG JNJ-64417184 Participants will receive Treatment E (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fasted condition) in treatment Period 1; followed by Treatment F (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment G (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Optional Panel 2: Treatment Sequence GFE JNJ-64417184 Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Panel 1: Treatment Sequence ABDC JNJ-64417184 Participants will receive Treatment A (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fasted condition) in treatment Period 1; followed by Treatment B (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment D (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3, followed by Treatment C (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fasted condition) in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Panel 1: Treatment Sequence BCAD JNJ-64417184 Participants will receive Treatment B in treatment Period 1; followed by Treatment C in treatment Period 2; followed by Treatment A in treatment Period 3, followed by Treatment D in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Optional Panel 2: Treatment Sequence FEG JNJ-64417184 Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Panel 1: Treatment Sequence DACB JNJ-64417184 Participants will receive Treatment D in treatment Period 1; followed by Treatment A in treatment Period 2; followed by Treatment C in treatment Period 3, followed by Treatment B in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Optional Panel 2: Treatment Sequence GEF JNJ-64417184 Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. Optional Panel 2: Treatment Sequence EGF JNJ-64417184 Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 Up to Day 6 Cmax is the maximum observed plasma analyte concentration.
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-64417184 Up to Day 6 AUC (0-last) is area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184 Up to Day 6 AUC (0-infinity) is the area under the plasma analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Up to 28 days An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment.
Acceptability of the JNJ-64417184 Formulation as Assessed by Participant Up to 28 days The acceptability of the JNJ-64417184 formulations will be assessed by the participants using a questionnaire designed to rate the taste and smell as well as the overall acceptability of the formulations. The questionnaire will consist of a visual analogue scale to rate 5 items (sweetness, bitterness, aroma type, aroma strength, and smell) as well as overall acceptability.
Trial Locations
- Locations (1)
Clinical Pharmacology Unit
🇧🇪Merksem, Belgium