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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000167-24 | EudraCT Number | ||
| 64251330EDI1003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate: systemic and local gut (rectum and sigmoid colon) exposure to JNJ-64251330, local tissue Pharmacodynamics (PD) using gut (rectum and sigmoid colon) biopsies (Part 1) and the effect of food on the rate and extent of absorption of JNJ-64251330 from oral tablet dosed with or without food (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment A (JNJ-64251330) | Experimental | Participants will receive JNJ-64251330 (dose 1), once daily for 5 days under fasting conditions. |
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| Part 1: Treatment B (JNJ-64251330) | Experimental | Participants will receive JNJ-64251330 (dose 1), twice daily for 5 days under fasting conditions. |
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| Part 1: Treatment C (JNJ-64251330) | Experimental | Participants will receive JNJ-64251330 (dose 2), twice daily for 5 days under fasting conditions. |
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| Part 1: Treatment D (JNJ-64251330) | Active Comparator | Participants will receive tofacitinib tablet twice daily for 5 days under fasting conditions. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64251330 | Drug | JNJ-64251330 tablet will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Plasma Concentrations (Cmax) of JNJ-64251330 | Cmax is maximum observed plasma concentrations during a dosing interval. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h Postdose on Day 1 and Day 5; Predose on Day 2 |
| Part 1: Trough Observed Plasma Concentration (Ctrough) of JNJ-64251330 | Ctrough is observed plasma concentration immediately prior to dosing on Day 5 and 24 h after last dose. | Predose, 24 hour (h) Postdose on Day 5 |
| Part 1: Area Under the Plasma Concentration-Time Curve from 0 to 24 Hour (AUC [0-24 h]) of JNJ-64251330 | AUC (0-24 h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose will be evaluated. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 14 h, 24 h Postdose on Day 1 and Day 5; Predose on Day 2 |
| Part 1: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUC [0-Last]) of JNJ-64251330 | 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. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 14 h, 24 h Postdose on Day 1 and Day 5; Predose on Day 2 |
| Part 1: Biopsy Gut (Rectum and Sigmoid Colon) Tissue Concentration of JNJ-64251330 | 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. | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Incidence of Adverse Events (AEs) | Incidence of AEs will be evaluated to assess the safety and tolerability of JNJ 64251330 and tofacitinib. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. | Up to 35 days (Part 1); Up to 39 days (Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38159266 | Derived | Ma X, Borzillo G, Kothe MJC, Sanga M, Chu G, Greger JG, Deiteren A, Attiyeh E. A Phase I, Randomized, Multi-Dose Study to Evaluate the Enteric Selectivity and Safety of JAK Inhibitor, Lorpucitinib, in Healthy Participants. Clin Pharmacol Ther. 2024 May;115(5):1075-1084. doi: 10.1002/cpt.3170. Epub 2024 Jan 29. |
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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
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| 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. |
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| Tofacitinib | Drug | Tofacitinib tablets will be administered orally. |
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| Part 1: Change from Baseline in Levels of Phosphorylated Signal Transducer and Activator of Transcription (pSTATs) and other Pan-Janus kinase (JAK) Biomarkers |
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). |
| Baseline up to Day 6 |
| Part 2: Maximum Observed Plasma Concentrations (Cmax) of JNJ-64251330 | Cmax is maximum observed plasma concentrations during a dosing interval. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h Postdose on Day 1; 24 h, 32 h, 36 h Postdose on Day 2; 48 h Postdose on Day 3 |
| Part 2: Time to achieve Maximum Observed Plasma Concentration (Tmax) of JNJ-64251330 | Tmax is the maximum observed plasma concentration. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h Postdose on Day 1; 24 h, 32 h, 36 h Postdose on Day 2; 48 h Postdose on Day 3 |
| Part 2: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 Hour (AUC [0-24 h]) of JNJ-64251330 | AUC (0-24 h) defined as area under the plasma concentration-time curve from time 0 to 24 hour postdose will be evaluated. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h Postdose on Day 2 |
| Part 2: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUC [0-Last]) of JNJ-64251330 | 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. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h Postdose on Day 1; 24 h, 32 h, 36 h Postdose on Day 2; 48 h Postdose on Day 3 |
| Part 2: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time (AUC [0-Infinite]) of JNJ-64251330 | AUC (0-Infinite) defined as area under the analyte concentration versus time curve from time 0 to infinite time will be evaluated. | Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h Postdose on Day 1; 24 h, 32 h, 36 h Postdose on Day 2; 48 h Postdose on Day 3 |
| Parts 1 and 2: Number of Participants with Severity of AEs | Severity assessment for an AE will be completed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 5.0). Severity grades ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or Disabling and Grade 5= Death. | Up to 35 days (Part 1); Up to 39 days (Part 2) |
| Part 1: Ratio of Gut (Rectum and Sigmoid colon) to Systemic Exposure | Ratio of gut (rectum and sigmoid colon) to systemic exposure will be evaluated to assess the relative exposure of JNJ-64251330 versus tofacitinib. | Up to Day 6 |