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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004946-12 | EudraCT Number | ||
| 70075200SLE1001 | Other Identifier | Janssen Research & Development, LLC |
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Program terminated prior to enrolling subjects
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | 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. |
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| Part 2: Multiple Ascending Dose (MAD) | Experimental | 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. |
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| Part 3: Single-dose Oral Solid Formulation (Optional) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-70075200 | Drug | JNJ-70075200 solution or solid formulations will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) | 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. | Up to 1 year and 1 month |
| Percentage of Participants with Serious Adverse Events (SAEs) | 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. | Up to 1 year and 1 month |
| Number of Participants with Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs will be assessed. | Up to 1 year and 1 month |
| Number of Participants with Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination will be assessed. | Up to 1 year and 1 month |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported. | Up to 1 year and 1 month |
| Change From Baseline in QTc Interval |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time | 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: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trials | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Drug | Placebo solution will be administered orally. |
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Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG). |
| Baseline, up to 1 year and 1 month |
| Change from Baseline in Heart Rate (HR) | Change from baseline in HR will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Change from Baseline in QRS Interval | Change from baseline in QRS interval will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Change from Baseline in PR Interval | Change from baseline in PR interval will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Change From Baseline in QT Interval | Change from baseline in QT interval will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect) | Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS. | Predose, up to 72 hours postdose (up to Day 4) |
| Part 1 and 3: Percentage of Participants with TEAEs (Food Effect) | 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. | Up to 1 year and 1 month |
| Part 1 and 3: Percentage of Participants with SAEs (Food Effect) | 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. | Up to 1 year and 1 month |
| Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect) | Number of participants with clinically significant changes in vital signs will be assessed. | Up to 1 year and 1 month |
| Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect) | Number of participants with clinically significant changes in physical examination will be assessed. | Up to 1 year and 1 month |
| Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect) | Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported. | Up to 1 year and 1 month |
| Part 1 and 3: Change From Baseline in QTc Interval (Food Effect) | Change from baseline in QTc interval using Fridericia method will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Part 1 and Part 3: Change from Baseline in HR (Food Effect) | Change from baseline in HR will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect) | Change from baseline in QRS interval will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect) | Change from baseline in PR interval will be measured by ECG. | Baseline, up to 1 year and 1 month |
| Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect) | Change from baseline in QT interval will be measured by ECG. | Baseline, up to 1 year and 1 month |