Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 68179280IBD1001 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Participants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition. |
|
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Participants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition. |
|
| Part 3: Multiple Dose Alternative Formulation (Optional) | Experimental | Participants will receive multiple oral doses of an alternative JNJ-68179280 formulation once daily in Cohort 1 and Cohort 2 (optional) on Days 1 through 14 under fasted or fed condition. Doses in Part 3 will depend on the safety, tolerability, PK and pharmacodynamics data from Part 1 and Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-68179280 | Drug | JNJ-68179280 will be administered as an oral capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number 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 35 days |
| Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) | SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 35 days |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) will be reported. | Up to 35 days |
| Number of Participants with Clinically Significant Abnormalities in Physical Examination | Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported. | Up to 35 days |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests | Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported. | Up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2 and 3: Plasma Concentration of JNJ-68179280 | Plasma concentration of JNJ-68179280 will be reported. | Up to 19 days |
| Part 1, 2 and 3: Urine Concentration of JNJ-68179280 | Urine samples will be analyzed to determine the concentration of JNJ-68179280. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Matching placebo will be administered as an oral capsule. |
|
| Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs) | Number of participants with clinically significant abnormalities in ECGs will be reported. | Up to 28 days |
| Up to 19 days |
| Part 1, 2 and 3: Stool Concentration of JNJ-68179280 | Stool samples will be analyzed to determine the concentration of JNJ-68179280. | Up to 16 days |
| Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition | Plasma concentration of JNJ-68179280 under fasted condition will be reported. | Up to Day 6 |
| Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition | Plasma concentration of JNJ-68179280 under fed condition will be reported. | Up to 13 days |
| Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition | Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fasted condition. | Up to Day 6 |
| Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition | Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fed conditions. | Up to 13 days |
| Part 1: Number of Participants with TEAEs Under Fasted Condition | 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 16 days |
| Part 1: Number of Participants with TEAEs Under Fed Condition | 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 23 days |
| Part 1: Number of Participants with SAEs Under Fasted Condition | SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 16 days |
| Part 1: Number of Participants with SAEs Under Fed Condition | SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 23 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition | Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) under fasted condition will be reported. | Up to 16 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition | Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) under fed condition will be reported. | Up to 23 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition | Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fasted condition will be reported. | Up to 16 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition | Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fed condition will be reported. | Up to 23 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition | Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fasted condition will be reported. | Up to 16 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition | Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fed condition will be reported. | Up to 23 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition | Number of participants with clinically significant abnormalities in ECGs under fasted condition will be reported. | Up to 16 days |
| Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition | Number of participants with clinically significant abnormalities in ECGs under fed condition will be reported. | Up to 23 days |