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JNJ-68179280 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 days
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a new drug compared to placebo. The drug will be given to healthy participants either once or twice a day for 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Number of Participants with Clinically Significant Abnormalities in Physical Examination
+3 more
Secondary outcome measures
Part 1, 2 and 3: Plasma Concentration of JNJ-68179280
Part 1, 2 and 3: Stool Concentration of JNJ-68179280
Part 1, 2 and 3: Urine Concentration of JNJ-68179280
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: Multiple Dose Alternative Formulation (Optional)Experimental Treatment1 Intervention
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.
Group II: Part 2: Multiple Ascending Dose (MAD)Experimental Treatment2 Interventions
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.
Group III: Part 1: Single Ascending Dose (SAD)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-68179280
2021
Completed Phase 1
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,214 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,811 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this research endeavor?

"This clinical trial requires that 118 participants, ranging in age from 18 to 60 and with no pre-existing conditions, fulfill the following criteria: They must not have smoked or used nicotine products for at least six months prior to screening; female patients need a negative pregnancy test before check-in on either Day -2 or Day -1. At both screening and check-in, their physical examination needs to be healthy as well as all of the results from their serum chemistry panel (excluding liver enzymes), hematology tests, blood coagulation tests and urinalysis. Furthermore, they are required to have specific laboratory values during both stages including"

Answered by AI

Are the elderly being considered for inclusion in this research endeavor?

"This medical experiment is accepting participants who are of legal age and younger than 60 years old."

Answered by AI

How many people have subscribed to this experiment thus far?

"Affirmative. According to information hosted on clinicaltrials.gov, this particular medical trial is presently seeking participants and was originally posted on May 5th 2021. 118 patients are needed from 1 site for the study's completion."

Answered by AI

What are the chief aims of this clinical investigation?

"This 35 day trial seeks to assess the number of participants displaying clinically significant abnormal vital signs. Secondary evaluation focuses on measuring clinically noteworthy ECG distortions while fasting, plasma concentration levels after consuming JNJ-68179280, and physical examinations (including general appearance, respiratory system assessment and cardiovascular checkup) post ingestion."

Answered by AI

Could the use of JNJ-68179280 potentially be detrimental to individuals?

"As it is merely a Phase 1 trial, and therefore still has limited evidence of efficacy or safety, JNJ-68179280 was rated a score of 1."

Answered by AI

Are there any vacancies to partake in this research project?

"Affirmative. According to clinicaltrials.gov, this study remains open and was originally published on May 5th 2021and last modified November 22nd 2022. The research is recruiting 118 patients at a single facility."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
How old are they?
18 - 65
What site did they apply to?
Celerion
What portion of applicants met pre-screening criteria?
Met criteria
~25 spots leftby Apr 2025