JNJ-88260237 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Celerion, Lincoln, NE
Healthy Subjects (HS)
JNJ-88260237 - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 7 Secondary · Reporting Duration: Up to Day 14

Up to Day 14
Number of Participants with Adverse Events (AEs)
Up to Day 7
Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237
Apparent Volume of Distribution (Vz/F) of JNJ-88260237
Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237
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
Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237
Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of Participants with Abnormalities in Physical Examinations
Number of Participants with Abnormalities in Vital Signs
Terminal Half-life (T1/2) of JNJ-88260237
Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

JNJ-88260237
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: JNJ-88260237 · Has Placebo Group · Phase 1

JNJ-88260237
Drug
Experimental Group · 1 Intervention: JNJ-88260237 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 14
Closest Location: Celerion · Lincoln, NE
2011First Recorded Clinical Trial
116 TrialsResearching Healthy Subjects (HS)
198 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of 18 to 30 kg/m^2 (inclusive).
You are a female and not of childbearing potential.
You are female and 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.
You are a male participant and you 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.