A Study of JNJ-70075200 in Healthy Participants
- Conditions
- Healthy
- Interventions
- Drug: JNJ-70075200Drug: Placebo
- Registration Number
- NCT04782661
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 3: Single-dose Oral Solid Formulation (Optional) JNJ-70075200 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. Part 2: Multiple Ascending Dose (MAD) Placebo 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. Part 1: Single Ascending Dose (SAD) JNJ-70075200 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. Part 1: Single Ascending Dose (SAD) Placebo 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. Part 2: Multiple Ascending Dose (MAD) JNJ-70075200 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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 PR Interval Baseline, up to 1 year and 1 month Change from baseline in PR interval will be measured by ECG.
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.
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).
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 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 QT Interval Baseline, up to 1 year and 1 month Change from baseline in QT interval will be measured by ECG.
- Secondary Outcome Measures
Name Time Method 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, 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 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 HR (Food Effect) Baseline, up to 1 year and 1 month Change from baseline in HR will be measured by ECG.
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 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.
Trial Locations
- Locations (1)
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
🇳🇱Groningen, Netherlands