Healthy
Conditions
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
Interventions
DRUGJNJ-88260237
JNJ-88260237 will be administered orally.
DRUGPlacebo
Matching placebo will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed