A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- JNJ-70075200
- Conditions
- Healthy
- Sponsor
- Janssen Research & Development, LLC
- Locations
- 1
- Primary Endpoint
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: JNJ-70075200
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.
Intervention: Placebo
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.
Intervention: JNJ-70075200
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.
Intervention: Placebo
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.
Intervention: JNJ-70075200
Outcomes
Primary Outcomes
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: 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
Time Frame: 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)
Time Frame: Baseline, up to 1 year and 1 month
Change from baseline in HR will be measured by ECG.
Change from Baseline in PR Interval
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, up to 1 year and 1 month
Change from baseline in QT interval will be measured by ECG.
Secondary Outcomes
- Part 1 and 3: Percentage of Participants with SAEs (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)(Baseline, up to 1 year and 1 month)
- 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))
- Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1 and Part 3: Change from Baseline in HR (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)(Predose, up to 72 hours postdose (up to Day 4))
- Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)(Up to 1 year and 1 month)
- Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)(Baseline, up to 1 year and 1 month)