A Study of JNJ-69095897 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-69095897; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04920578

2021-000609-26 (EudraCT Number)

CR108935

69095897EDI1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: JNJ-69095897

Part 2: Single Dose Cohort (Open-label)

Experimental group

Description:

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

Treatment:

Drug: JNJ-69095897

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

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: JNJ-69095897