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JNJ-64251330

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Dec 2, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04552197A Study of JNJ-64251330 in Healthy ParticipantsPHASE1 COMPLETED 36 — — Sep 2, 2020Dec 29, 2020Dec 2, 20221 Belgium
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Study Endpoints
Primary Endpoints
Part 1: Maximum Observed Plasma Concentrations (Cmax) of JNJ-64251330
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

Cmax is maximum observed plasma concentrations during a dosing interval.

Part 1: Trough Observed Plasma Concentration (Ctrough) of JNJ-64251330
Predose, 24 hour (h) Postdose on Day 5

Ctrough is observed plasma concentration immediately prior to dosing on Day 5 and 24 h after last dose.

Part 1: Area Under the Plasma Concentration-Time Curve from 0 to 24 Hour (AUC [0-24 h]) of JNJ-64251330
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

AUC (0-24 h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose will be evaluated.

Part 1: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUC [0-Last]) of JNJ-64251330
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

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.

Part 1: Biopsy Gut (Rectum and Sigmoid Colon) Tissue Concentration of JNJ-64251330
Day 6

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.

Part 1: Change from Baseline in Levels of Phosphorylated Signal Transducer and Activator of Transcription (pSTATs) and other Pan-Janus kinase (JAK) Biomarkers
Baseline up to Day 6

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).

Part 2: Maximum Observed Plasma Concentrations (Cmax) of JNJ-64251330
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

Cmax is maximum observed plasma concentrations during a dosing interval.

Part 2: Time to achieve Maximum Observed Plasma Concentration (Tmax) of JNJ-64251330
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

Tmax is the maximum observed plasma concentration.

Part 2: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 Hour (AUC [0-24 h]) of JNJ-64251330
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

AUC (0-24 h) defined as area under the plasma concentration-time curve from time 0 to 24 hour postdose will be evaluated.

Part 2: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUC [0-Last]) of JNJ-64251330
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

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.

Part 2: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time (AUC [0-Infinite]) of JNJ-64251330
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

AUC (0-Infinite) defined as area under the analyte concentration versus time curve from time 0 to infinite time will be evaluated.

Secondary Endpoints
Parts 1 and 2: Incidence of Adverse Events (AEs)
Up to 35 days (Part 1); Up to 39 days (Part 2)
Parts 1 and 2: Number of Participants with Severity of AEs
Up to 35 days (Part 1); Up to 39 days (Part 2)
Part 1: Ratio of Gut (Rectum and Sigmoid colon) to Systemic Exposure
Up to Day 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part 1: Treatment A (JNJ-64251330)EXPERIMENTALParticipants will receive JNJ-64251330 (dose 1), once daily for 5 days under fasting conditions.
Part 1: Treatment B (JNJ-64251330)EXPERIMENTALParticipants will receive JNJ-64251330 (dose 1), twice daily for 5 days under fasting conditions.
Part 1: Treatment C (JNJ-64251330)EXPERIMENTALParticipants will receive JNJ-64251330 (dose 2), twice daily for 5 days under fasting conditions.
Part 1: Treatment D (JNJ-64251330)ACTIVE_COMPARATORParticipants will receive tofacitinib tablet twice daily for 5 days under fasting conditions.
Part 2: Treatment EF (JNJ-64251330)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
JNJ-64251330DRUGJNJ-64251330 tablet will be administered orally.
TofacitinibDRUGTofacitinib tablets will be administered orally.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI; weight \[kilogram {kg}\]/height\^2 \[meter {m}\]\^2) between 18.0 and 30.0 kilograms per meter square (kg/m\^2) (inclusive), and body weight not less than 50.0 kg * 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, in...

Countries:Belgium
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