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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-88260237; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05541315

88260237CKD1001 (Other Identifier)

CR109227

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

JNJ-88260237

Experimental group

Description:

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.

Treatment:

Drug: JNJ-88260237

Placebo

Placebo Comparator group

Description:

Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1.

Treatment:

Drug: Placebo