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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-88260237; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-88260237; JNJ-88260237 will be administered orally.
Placebo Comparator: Placebo; Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1.	Drug: Placebo; Matching placebo will be administered orally.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR109227; 88260237CKD1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No