Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64251330 · 2 trials · 2 indications
Percentage change from baseline in colorectal polyp burden for all polyps (the sum of the polyp diameters) at Week 24 will be reported.
Percentage change from baseline in colorectal polyp burden (sum of the polyp diameters) for polyps greater than or equal to (\>=) 2 millimeters (mm) at Week 24 will be reported.
Cmax is maximum observed plasma concentrations during a dosing interval.
Ctrough is observed plasma concentration immediately prior to dosing on Day 5 and 24 h after last dose.
AUC (0-24 h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose will be evaluated.
AUC (0-Last) is defined as area under the plasma concentration versus time curve from time 0 to time of the last quantifiable concentration will be evaluated.
Biopsy gut (rectum and sigmoid colon) tissue concentration of JNJ-64251330 will be measured using liquid chromatography-mass spectrometry/mass spectrometry (LC MS/MS) assay method to evaluate systemic and local gut (rectum and sigmoid colon) exposure to JNJ-64251330.
Change from baseline in levels of pSTATs and other JAK biomarkers in gut (rectum and sigmoid colon) biopsies as a function of compound and dose will be measured to evaluate local tissue pharmacodynamics (PD).
Cmax is maximum observed plasma concentrations during a dosing interval.
Tmax is the maximum observed plasma concentration.
AUC (0-24 h) defined as area under the plasma concentration-time curve from time 0 to 24 hour postdose will be evaluated.
AUC (0-Last) defined as area under the plasma concentration versus time curve from time 0 to time of the last quantifiable concentration will be evaluated.
AUC (0-Infinite) defined as area under the analyte concentration versus time curve from time 0 to infinite time will be evaluated.
| Arm | Type | Description |
|---|---|---|
| JNJ-64251330 | EXPERIMENTAL | Participants will receive oral dose of JNJ-64251330 twice daily for 24 Weeks. |
| Part 1: Treatment A (JNJ-64251330) | EXPERIMENTAL | Participants will receive JNJ-64251330 (dose 1), once daily for 5 days under fasting conditions. |
| Part 1: Treatment B (JNJ-64251330) | EXPERIMENTAL | Participants will receive JNJ-64251330 (dose 1), twice daily for 5 days under fasting conditions. |
| Part 1: Treatment C (JNJ-64251330) | EXPERIMENTAL | Participants will receive JNJ-64251330 (dose 2), twice daily for 5 days under fasting conditions. |
| Part 1: Treatment D (JNJ-64251330) | ACTIVE_COMPARATOR | Participants will receive tofacitinib tablet twice daily for 5 days under fasting conditions. |
| Part 2: Treatment EF (JNJ-64251330) | EXPERIMENTAL | Participants will receive a single dose of JNJ-64251330 (dose 2), on Day 1 once under fasting conditions (Treatment E) in Period 1 followed by a single dose of JNJ-64251330 (dose 2), on Day 1 once with high fat breakfast (Treatment F) in Period 2. There will be a minimum of 5 days washout between dosing in the two treatment periods. |
| Part 2: Treatment FE (JNJ-64251330) | EXPERIMENTAL | Participants will receive a single dose of JNJ-64251330 (dose 2), on Day 1 once with high fat breakfast (Treatment F) in Period 1 followed by a single dose of JNJ-64251330 (dose 2), on Day 1 once under fasting conditions (Treatment E) in Period 2. There will be a minimum of 5 days washout between dosing in the two treatment periods. |
| Name | Type | Description |
|---|---|---|
| JNJ-64251330 | DRUG | JNJ-64251330 tablets will be administered orally. |
| Tofacitinib | DRUG | Tofacitinib tablets will be administered orally. |
Inclusion Criteria: * Genetic diagnosis of classical familial adenomatous polyposis (FAP) (adenomatous polyposis coli \[APC\] germline mutation or obligate carrier) with disease involvement of the colorectum * At least 6 polyps greater than or equal to (\>=) 2 millimeters (mm) in diameter in the re...
JNJ-64251330 is an investigational small molecule being studied for gastrointestinal conditions, specifically in healthy participants and in people with adenomatous polyposis coli, a condition related to familial adenomatous polyposis. It is in Phase 1 clinical development and is not yet approved.
JNJ-64251330 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is in Phase 1 clinical development for gastrointestinal indications.
JNJ-64251330 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy participants and one in participants with adenomatous polyposis coli. The drug is investigational and has not been approved.
JNJ-64251330 has been studied in two completed Phase 1 trials. NCT04552197 enrolled 36 healthy participants in Belgium. NCT05014360 enrolled 42 participants with adenomatous polyposis coli across the United States, France, Germany, Netherlands, Puerto Rico, South Korea, and Spain.
JNJ-64251330 is the primary name for this investigational small molecule. No alternative names have been reported for this compound in clinical development.