A Study of JNJ-69095897 in Healthy Participants

NCT04920578 | Terminated Phase 1

• 3 other identifiers: CR1089352021-000609-2669095897EDI1001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Plasma and CSF Concentration of Endogenous Metabolites

  Day 1

Study Arms (3)

Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind)

EXPERIMENTAL

Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8.

Drug: JNJ-69095897; Other: Placebo

Part 2: Single Dose Cohort (Open-label)

EXPERIMENTAL

Healthy male participants will receive JNJ-69095897 orally in Cohort 9.

Drug: JNJ-69095897

Part 3: Single or Divided Dose Cohort (Double-blind)

EXPERIMENTAL

Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10.

Drug: JNJ-69095897; Other: Placebo

Interventions

JNJ-69095897 DRUG

JNJ-69095897 will be administered orally in Parts 1, 2 and 3.

Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind); Part 2: Single Dose Cohort (Open-label); Part 3: Single or Divided Dose Cohort (Double-blind)

Placebo OTHER

Matching placebo will be administered orally in Parts 1 and 3.

Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind); Part 3: Single or Divided Dose Cohort (Double-blind)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

Location

Study Officials

• Jannsen Research & Development, LLC Clinical Trial

  Jannsen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 10, 2021
• Study Start: June 16, 2021
• Primary Completion: January 27, 2023
• Study Completion: February 27, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)