A Study of JNJ-70075200 in Healthy Participants
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Single Ascending Dose (SAD) Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition. Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days. |
Drug: JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.
Drug: Placebo
Placebo solution will be administered orally.
|
| Experimental: Part 2: Multiple Ascending Dose (MAD) After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition. |
Drug: JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.
Drug: Placebo
Placebo solution will be administered orally.
|
| Experimental: Part 3: Single-dose Oral Solid Formulation (Optional) Participants will receive oral dose of JNJ-70075200 on Day 1 in Cohort 1 under fasted condition. Part 3 will start after obtaining a formal regulatory/ethical approval. |
Drug: JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [Up to 1 year and 1 month]
An adverse event (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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
- Percentage of Participants with Serious Adverse Events (SAEs) [Up to 1 year and 1 month]
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
- Number of Participants with Clinically Significant Changes in Vital Signs [Up to 1 year and 1 month]
Number of participants with clinically significant changes in vital signs will be assessed.
- Number of Participants with Clinically Significant Changes in Physical Examination [Up to 1 year and 1 month]
Number of participants with clinically significant changes in physical examination will be assessed.
- Number of Participants With Clinically Significant Laboratory Abnormalities [Up to 1 year and 1 month]
Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
- Change From Baseline in QTc Interval [Baseline, up to 1 year and 1 month]
Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
- Change from Baseline in Heart Rate (HR) [Baseline, up to 1 year and 1 month]
Change from baseline in HR will be measured by ECG.
- Change from Baseline in QRS Interval [Baseline, up to 1 year and 1 month]
Change from baseline in QRS interval will be measured by ECG.
- Change from Baseline in PR Interval [Baseline, up to 1 year and 1 month]
Change from baseline in PR interval will be measured by ECG.
- Change From Baseline in QT Interval [Baseline, up to 1 year and 1 month]
Change from baseline in QT interval will be measured by ECG.
Secondary Outcome Measures
- Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time [Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)]
Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
- Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect) [Predose, up to 72 hours postdose (up to Day 4)]
Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS.
- Part 1 and 3: Percentage of Participants with TEAEs (Food Effect) [Up to 1 year and 1 month]
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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
- Part 1 and 3: Percentage of Participants with SAEs (Food Effect) [Up to 1 year and 1 month]
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
- Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect) [Up to 1 year and 1 month]
Number of participants with clinically significant changes in vital signs will be assessed.
- Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect) [Up to 1 year and 1 month]
Number of participants with clinically significant changes in physical examination will be assessed.
- Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect) [Up to 1 year and 1 month]
Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
- Part 1 and 3: Change From Baseline in QTc Interval (Food Effect) [Baseline, up to 1 year and 1 month]
Change from baseline in QTc interval using Fridericia method will be measured by ECG.
- Part 1 and Part 3: Change from Baseline in HR (Food Effect) [Baseline, up to 1 year and 1 month]
Change from baseline in HR will be measured by ECG.
- Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect) [Baseline, up to 1 year and 1 month]
Change from baseline in QRS interval will be measured by ECG.
- Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect) [Baseline, up to 1 year and 1 month]
Change from baseline in PR interval will be measured by ECG.
- Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect) [Baseline, up to 1 year and 1 month]
Change from baseline in QT interval will be measured by ECG.
Eligibility Criteria
Criteria
Inclusion criteria:
-
Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
-
Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
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No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
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Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m2) (BMI = weight/height2) (inclusive)
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All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening
Exclusion criteria:
-
Participants having a history of liver or renal insufficiency (estimated creatinine clearance [CL] below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
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Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) for males, and >470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
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Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
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Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | Netherlands | 9728 NZ |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trials, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108971
- 2020-004946-12
- 70075200SLE1001