Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Secondary |
Part 1, 2 and 3: Plasma Concentration of JNJ-68179280 |
Plasma concentration of JNJ-68179280 will be reported. |
Up to 19 days |
|
Secondary |
Part 1, 2 and 3: Urine Concentration of JNJ-68179280 |
Urine samples will be analyzed to determine the concentration of JNJ-68179280. |
Up to 19 days |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|