Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04844463 | A Study of JNJ-68179280 in Healthy Participants | PHASE1 | COMPLETED | 94 | — | — | May 26, 2021 | Mar 13, 2023 | Feb 3, 2025 | 1 | United States |
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.
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.
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.
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Number of participants with clinically significant abnormalities in ECGs will be reported.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| JNJ-68179280 | DRUG | JNJ-68179280 will be administered as an oral capsule. |
| Placebo | OTHER | Matching placebo will be administered as an oral capsule. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents...