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Completed

NCT Number: NCT05541315

A Single Ascending Dose Study 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

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-88260237

Drug

JNJ-88260237 will be administered orally.

Placebo

Drug

Matching placebo will be administered orally.

Primary outcomes

  1. Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 14

    Number of participants with AEs will be reported.

  2. Cohort 5: Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 24

    Number of participants with AEs will be reported.

  3. Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs

    Time frame: 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.

  4. Cohort 5: Number of Participants with Abnormalities in Vital Signs

    Time frame: 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.

  5. Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)

    Time frame: Up to Day 7

    Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.

  6. Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)

    Time frame: Up to Day 21

    Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.

  7. Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters

    Time frame: Up to Day 7

    Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.

  8. Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters

    Time frame: Up to Day 21

    Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.

  9. Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations

    Time frame: Up to Day 7

    Number of participants with abnormalities in physical examinations will be reported.

  10. Cohort 5: Number of Participants with Abnormalities in Physical Examinations

    Time frame: Up to Day 21

    Number of participants with abnormalities in physical examinations will be reported.

Secondary outcomes

  1. Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237

    Time frame: 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.

  2. Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237

    Time frame: 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.

  5. Terminal Half-life (T1/2) of JNJ-88260237

    Time frame: 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.

  6. Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237

    Time frame: 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.

  7. Apparent Volume of Distribution (Vz/F) of JNJ-88260237

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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