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

Summary

This trial is testing a new drug called JNJ-68179280 to see if it is safe and well-tolerated when taken by mouth. Healthy participants will take the drug to monitor for any side effects. The goal is to ensure the drug's safety before it can be tested on patients with specific conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 35 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Do I qualify?Apply below to find out