A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants

Official Title
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A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-88260237
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening Body mass index (BMI) within the range 18 to 30 kilogram/meter^2 (kg/m^2) (inclusive) A female must be a) not of childbearing potential defined as postmenopausal or permanently sterile A female must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after administration of study intervention A male participant must agree not to donate sperm for the purpose of reproduction or plan to father a child during the study and for a minimum of 90 days after receiving study intervention Exclusion Criteria: History of liver (with the exception of Gilbert's syndrome or asymptomatic gallstones) or renal insufficiency (estimated glomerular filtration rate [eGFR] below 90 mL/minute at screening only); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances Any history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin) Had major surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has any surgery planned during the time the participant is expected to participate in the study or within 4 weeks after study intervention administration History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed) Any current active infections, including localized infections, or any recent history (within 4 weeks prior to administration of study intervention) of active infections, or a history of recurrent, severe, or chronic infections, or otherwise increased risk of infection

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-88260237<br>Participants will be randomized into 6 cohorts to receive single oral dose of JNJ-88260237 on Day 1. The doses in each cohort (Cohorts 2 to 4 and 6) will be escalated based on the safety and pharmacokinetics (PK) data of the previous cohort. For Cohort 5, participants will receive a single-dose of JNJ-82260237 in fasted conditions and a single dose of JNJ-82260237 in fed conditions with dosing sequence determined by randomization. | Drug: JNJ-88260237<br>* JNJ-88260237 will be administered orally.<br>|
| Placebo Comparator: Placebo<br>Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1. | Drug: Placebo<br>* Matching placebo will be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs) | Number of participants with AEs will be reported. | Up to Day 14 | 
| Cohort 5: Number of Participants with Adverse Events (AEs) | Number of participants with AEs will be reported. | Up to Day 24 | 
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported. | Up to Day 7 | 
| Cohort 5: Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported. | Up to Day 21 | 
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG) | Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported. | Up to Day 7 | 
| Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG) | Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported. | Up to Day 21 | 
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters | Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported. | Up to Day 7 | 
| Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters | Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported. | Up to Day 21 | 
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations will be reported. | Up to Day 7 | 
| Cohort 5: Number of Participants with Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations will be reported. | Up to Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237 | Cmax is defined as the maximum whole blood concentration of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 | 
| Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237 | Tmax is defined as the time to reach the maximum whole blood concentration of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 | 
| Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) of JNJ-88260237 | AUC (0-Last) is defined as the area under the whole blood concentration versus time curve from time zero to time of the last measurable concentration of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 | 
| Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237 | AUC (0-infinity) is defined as the area under the whole blood concentration versus time curve from time zero to infinite time of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 | 
| Terminal Half-life (T1/2) of JNJ-88260237 | T1/2 is defined as the terminal half-life of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 | 
| Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237 | CL/F is defined as apparent oral whole blood clearance of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 | 
| Apparent Volume of Distribution (Vz/F) of JNJ-88260237 | Vz/F is defined as the apparent volume of distribution of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |