A Study of JNJ-69095897 in Healthy Participants
- Registration Number
- NCT04920578
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind) JNJ-69095897 Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8. Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind) Placebo Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8. Part 3: Single or Divided Dose Cohort (Double-blind) Placebo Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10. Part 2: Single Dose Cohort (Open-label) JNJ-69095897 Healthy male participants will receive JNJ-69095897 orally in Cohort 9. Part 3: Single or Divided Dose Cohort (Double-blind) JNJ-69095897 Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10.
- Primary Outcome Measures
Name Time Method Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites Up to Day 2 CSF concentration of JNJ-69095897 and its possible metabolites will be reported.
Plasma Concentration of JNJ-69095897 and its Possible Metabolites Up to Day 14 Plasma concentration of JNJ-69095897 and its possible metabolites will be reported.
Number of Participants with Adverse Events (AEs) Up to Day 14 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.
Number of Participants with Electrocardiogram (ECG) Abnormalities Up to Day 14 Number of participants with ECG abnormalities will be reported.
Number of Participants with Clinical Laboratory Abnormalities (Chemistry, Hematology, Urinalysis) Up to Day 14 Number of participants with clinical laboratory abnormalities including chemistry, hematology and urinalysis will be reported.
Number of Participants with Vital Sign Abnormalities Up to Day 14 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.
Number of Participants with Holter Recording Abnormalities Up to Day 2 Number of participants with Holter recording abnormalities (including heart rate variability \[HRV\]) will be reported.
Part 1: Urine Concentration of JNJ-69095897 and its Possible Metabolites Up to Day 4 Urine concentration of JNJ-69095897 and its possible metabolites will be reported.
- Secondary Outcome Measures
Name Time Method Plasma and CSF Concentration of Endogenous Metabolites Day 1 Plasma and CSF concentrations of endogenous metabolites will be reported.
Trial Locations
- Locations (1)
Centre for Human Drug Research
🇳🇱Leiden, Netherlands