A Study of JNJ-68179280 in Healthy Participants

January 31, 2025 updated by: Janssen Research & Development, LLC

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-68179280 in Healthy Participants

The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (excluding liver enzymes) including hematology, blood coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Have the following pre study intervention clinical laboratory values during screening and check-in to the unit (Day -2 or Day -1): a. aspartate transaminase (AST) less than or equal to (<=) upper limit of normal (ULN), b. alanine aminotransferase (ALT) <= ULN, c. bilirubin <= ULN, d. alkaline phosphatase <= ULN, e. gamma-glutamyl transpeptidase (GGTP) <= ULN, f. albumin greater than or equal to (>=) lower limit of normal (LLN)
  • A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at check-in to the unit on Day -2 or Day -1
  • Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example: nicotine patch, vaping, hookah) for 3 months prior to screening

Exclusion Criteria:

  • History of liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • History of malignancy before screening (exceptions are squamous or basal cell carcinomas of the skin and carcinoma in situ of the cervix as long as they are considered cured with minimal risk of recurrence)
  • Has an active, acute or chronic infection
  • Has taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention
  • Has a positive urine drug screen and/or alcohol breath test during screening or on Day 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Single Ascending Dose (SAD)
Participants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition.
Drug: JNJ-68179280
JNJ-68179280 will be administered as an oral capsule.
Other: Placebo
Matching placebo will be administered as an oral capsule.
Experimental: Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition.
Drug: JNJ-68179280
JNJ-68179280 will be administered as an oral capsule.
Other: Placebo
Matching placebo will be administered as an oral capsule.
Experimental: Part 3: Multiple Dose Alternative Formulation (Optional)
Participants will receive multiple oral doses of an alternative JNJ-68179280 formulation once daily in Cohort 1 and Cohort 2 (optional) on Days 1 through 14 under fasted or fed condition. Doses in Part 3 will depend on the safety, tolerability, PK and pharmacodynamics data from Part 1 and Part 2.
Drug: JNJ-68179280
JNJ-68179280 will be administered as an oral capsule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 35 days
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to 35 days
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: Up to 35 days
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time Frame: Up to 35 days
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Time Frame: Up to 35 days
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.
Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Time Frame: Up to 35 days
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Up to 35 days
Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
Time Frame: Up to 28 days
Number of participants with clinically significant abnormalities in ECGs will be reported.
Up to 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1, 2 and 3: Plasma Concentration of JNJ-68179280
Time Frame: Up to 19 days
Plasma concentration of JNJ-68179280 will be reported.
Up to 19 days
Part 1, 2 and 3: Urine Concentration of JNJ-68179280
Time Frame: Up to 19 days
Urine samples will be analyzed to determine the concentration of JNJ-68179280.
Up to 19 days
Part 1, 2 and 3: Stool Concentration of JNJ-68179280
Time Frame: Up to 16 days
Stool samples will be analyzed to determine the concentration of JNJ-68179280.
Up to 16 days
Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition
Time Frame: Up to Day 6
Plasma concentration of JNJ-68179280 under fasted condition will be reported.
Up to Day 6
Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition
Time Frame: Up to 13 days
Plasma concentration of JNJ-68179280 under fed condition will be reported.
Up to 13 days
Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition
Time Frame: Up to Day 6
Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fasted condition.
Up to Day 6
Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition
Time Frame: Up to 13 days
Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fed conditions.
Up to 13 days
Part 1: Number of Participants with TEAEs Under Fasted Condition
Time Frame: Up to 16 days
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to 16 days
Part 1: Number of Participants with TEAEs Under Fed Condition
Time Frame: Up to 23 days
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to 23 days
Part 1: Number of Participants with SAEs Under Fasted Condition
Time Frame: Up to 16 days
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to 16 days
Part 1: Number of Participants with SAEs Under Fed Condition
Time Frame: Up to 23 days
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition
Time Frame: Up to 16 days
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) under fasted condition will be reported.
Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition
Time Frame: Up to 23 days
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) under fed condition will be reported.
Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition
Time Frame: Up to 16 days
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fasted condition will be reported.
Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition
Time Frame: Up to 23 days
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fed condition will be reported.
Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition
Time Frame: Up to 16 days
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fasted condition will be reported.
Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition
Time Frame: Up to 23 days
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fed condition will be reported.
Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition
Time Frame: Up to 16 days
Number of participants with clinically significant abnormalities in ECGs under fasted condition will be reported.
Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition
Time Frame: Up to 23 days
Number of participants with clinically significant abnormalities in ECGs under fed condition will be reported.
Up to 23 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108989
  • 68179280IBD1001 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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