A Study of JNJ-69095897 in Healthy Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 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 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 Holter Recording Abnormalities [Up to Day 2]
Number of participants with Holter recording abnormalities (including heart rate variability [HRV]) 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.
- 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.
- 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
- Plasma and CSF Concentration of Endogenous Metabolites [Day 1]
Plasma and CSF concentrations of endogenous metabolites will be reported.
Eligibility Criteria
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/m2) inclusive (BMI=weight/height2)
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Human Drug Research | Leiden | Netherlands | 2333 CL |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Jannsen Research & Development, LLC Clinical Trial, Jannsen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108935
- 2021-000609-26
- 69095897EDI1001