A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants
- Registration Number
- NCT05541315
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1. JNJ-88260237 JNJ-88260237 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.
- Primary Outcome Measures
Name Time Method Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG) Up to Day 21 Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters Up to Day 7 Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs) Up to Day 14 Number of participants with AEs will be reported.
Cohort 5: Number of Participants with Adverse Events (AEs) Up to Day 24 Number of participants with AEs will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs Up to Day 7 Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Cohort 5: Number of Participants with Abnormalities in Vital Signs Up to Day 21 Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG) Up to Day 7 Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters Up to Day 21 Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations Up to Day 7 Number of participants with abnormalities in physical examinations will be reported.
Cohort 5: Number of Participants with Abnormalities in Physical Examinations Up to Day 21 Number of participants with abnormalities in physical examinations will be reported.
- Secondary Outcome Measures
Name Time Method Terminal Half-life (T1/2) of JNJ-88260237 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 T1/2 is defined as the terminal half-life of JNJ-88260237.
Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 Cmax is defined as the maximum whole blood concentration of JNJ-88260237.
Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 Tmax is defined as the time to reach the maximum whole blood concentration of JNJ-88260237.
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 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 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.
Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 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.
Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 CL/F is defined as apparent oral whole blood clearance of JNJ-88260237.
Apparent Volume of Distribution (Vz/F) of JNJ-88260237 Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 Vz/F is defined as the apparent volume of distribution of JNJ-88260237.
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States