Approval Probability
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JNJ-68179280 · 1 trial · 1 indication
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...
JNJ-68179280 is an investigational small molecule drug being developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants. No therapeutic indication for JNJ-68179280 has been disclosed.
JNJ-68179280 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound in healthy participants.
JNJ-68179280 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials of JNJ-68179280 are currently listed.
JNJ-68179280 has been evaluated in one clinical trial, NCT04844463, titled A Study of JNJ-68179280 in Healthy Participants. That Phase 1 trial was completed and enrolled 94 healthy volunteers in the United States. It was randomized, double blind, and controlled.
The Phase 1 trial of JNJ-68179280, NCT04844463, was a randomized, double blind, controlled study conducted in the United States. It enrolled 94 healthy participants aged 18 years and older, of all sexes. The study has been completed.