A Study of JNJ-69095897 in Healthy Participants

A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-69095897 in Healthy Participants

The purpose of this study is to investigate the safety and tolerability of JNJ-69095897 versus placebo and to characterize the pharmacokinetic (PK) of JNJ-69095897 in blood, plasma, cerebrospinal fluid (CSF) and urine after single or divided oral dose administration in healthy participants.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-69095897; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Netherlands
  • Leiden, Netherlands, 2333 CL
    • Centre for Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Otherwise, healthy based on physical examination, medical history, vital signs, orthostatic blood pressure measurements and 12-lead Electrocardiography (ECG) (means of triplicate ECG, inclusive, QT corrected according to Fridericia's formula [QTcF] less than or equal to [<=] 450 millisecond [msec] for males and <= 470 msec for females) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, blood pressure and heart rate, which are not considered to be of clinical significance by the investigator, are acceptable, with the exception of bradycardia <= 45 beats per minutes (bpm) on 12-lead safety ECG, that will be exclusionary at screening, admission to the clinical unit or prior to the first dose on the dosing day
• Otherwise, healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, hematology, or urinalysis are outside the normal reference ranges, the participant may be included at the discretion of the investigator, provided the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• Participant has a body mass index (BMI) between 18.0 and 30.0 kilogram/meter square (kg/m^2) inclusive (BMI=weight/height^2)
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study. Participation in the pharmacogenomic part of the study is mandatory

Exclusion Criteria:

• Has a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other significant cardiac disease, orthostatic hypotension, liver or renal insufficiency, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers should exclude the participant
• Has a diagnosis or suspicions of any sleep disorder in the last 6 months or current complaints of sleep disturbance, irregular sleep schedule or shift work; habitual daytime naps; travel across time zones in the last 4 weeks or daytime symptoms attributable to unsatisfactory sleep
• Has a history of or current major or clinically relevant psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) (example, mood, anxiety disorders, psychotic disorder et cetera)
• Has had a clinically significant acute illness within 7 days prior to study intervention administration
• Has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind); Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8.	Drug: JNJ-69095897; JNJ-69095897 will be administered orally in Parts 1, 2 and 3.; Other: Placebo; Matching placebo will be administered orally in Parts 1 and 3.
Experimental: Part 2: Single Dose Cohort (Open-label); Healthy male participants will receive JNJ-69095897 orally in Cohort 9.	Drug: JNJ-69095897; JNJ-69095897 will be administered orally in Parts 1, 2 and 3.
Experimental: Part 3: Single or Divided Dose Cohort (Double-blind); Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10.	Drug: JNJ-69095897; JNJ-69095897 will be administered orally in Parts 1, 2 and 3.; Other: Placebo; Matching placebo will be administered orally in Parts 1 and 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Vital Sign Abnormalities	Number of participants with vital sign abnormalities including heart/pulse rate, systolic blood pressure, diastolic blood pressure, tympanic body temperature and respiratory rate will be reported.	Up to Day 14
Number of Participants with Clinical Laboratory Abnormalities (Chemistry, Hematology, Urinalysis)	Number of participants with clinical laboratory abnormalities including chemistry, hematology and urinalysis will be reported.	Up to Day 14
Number of Participants with Adverse Events (AEs)	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.	Up to Day 14
Number of Participants with Electrocardiogram (ECG) Abnormalities	Number of participants with ECG abnormalities will be reported.	Up to Day 14
Number of Participants with Holter Recording Abnormalities	Number of participants with Holter recording abnormalities (including heart rate variability [HRV]) will be reported.	Up to Day 2
Plasma Concentration of JNJ-69095897 and its Possible Metabolites	Plasma concentration of JNJ-69095897 and its possible metabolites will be reported.	Up to Day 14
Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites	CSF concentration of JNJ-69095897 and its possible metabolites will be reported.	Up to Day 2
Part 1: Urine Concentration of JNJ-69095897 and its Possible Metabolites	Urine concentration of JNJ-69095897 and its possible metabolites will be reported.	Up to Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma and CSF Concentration of Endogenous Metabolites	Plasma and CSF concentrations of endogenous metabolites will be reported.	Day 1

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Jannsen Research & Development, LLC Clinical Trial, Jannsen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CR108935; 2021-000609-26 (EudraCT Number); 69095897EDI1001 (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: No
• Studies a U.S. FDA-regulated device product: No