Clinical trial NCT04920578: A Study of JNJ-69095897 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 14
measure: Number of Participants with Clinical Laboratory Abnormalities (Chemistry, Hematology, Urinalysis)
timeFrame: Up to Day 14
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 14
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 14
measure: Number of Participants with Holter Recording Abnormalities
timeFrame: Up to Day 2
measure: Plasma Concentration of JNJ-69095897 and its Possible Metabolites
timeFrame: Up to Day 14
measure: Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites
timeFrame: Up to Day 2
measure: Part 1: Urine Concentration of JNJ-69095897 and its Possible Metabolites
timeFrame: Up to Day 4
Secondary outcomes:
measure: Plasma and CSF Concentration of Endogenous Metabolites
timeFrame: Day 1
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Jannsen Research & Development, LLC
name: Jannsen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: