Clinical trial NCT05541315: A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants
Official title: A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 14
measure: Cohort 5: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 24
measure: Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to Day 7
measure: Cohort 5: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to Day 21
measure: Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to Day 7
measure: Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to Day 21
measure: Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
timeFrame: Up to Day 7
measure: Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
timeFrame: Up to Day 21
measure: Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations
timeFrame: Up to Day 7
measure: Cohort 5: Number of Participants with Abnormalities in Physical Examinations
timeFrame: Up to Day 21
Secondary outcomes:
measure: Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
measure: Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
measure: 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
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
measure: Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
measure: Terminal Half-life (T1/2) of JNJ-88260237
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
measure: Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
measure: Apparent Volume of Distribution (Vz/F) of JNJ-88260237
timeFrame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: