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JNJ-64417184 600

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Feb 3, 2025

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-64417184 600 · 1 trial · 1 indication

Phase 1 1
NCT03952507A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy ParticipantsHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative Bioavailability of JNJ-64417184
Day 1,8,15:Predose, 0.5,1,2,3,4,6,8,10,12 and 18 hours (hrs) postdose; Day 2,9,16:24,36hrs postdose; Day 3,10,17:48 hrs postdose; Day 4,11,18:72hrs postdose; Day 5,12,19:96hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21

The relative bioavailability based on Cmax, AUC(0last), and AUC(0-infinity) will be estimated as 100\*Test/Reference where Test is tablet formulation of JNJ-64417184 and Reference is suspension formulation of JNJ-64417184 administered orally in a fasted state.

Secondary Endpoints

Plasma Concentration of JNJ-64417184 in Fasted Conditions
Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Plasma Concentration of JNJ-64417184 in fed and Fasted Conditions
Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in fed State
Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group 1: JNJ-64417184EXPERIMENTALParticipants will receive JNJ-64417184 600 milligram (mg) oral tablet under fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg oral tablet in fed conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg as oral suspension in fasted condition on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Group 2: JNJ-64417184EXPERIMENTALParticipants will receive JNJ-64417184 600 mg oral tablet under fed conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Group 3: JNJ-64417184EXPERIMENTALParticipants will receive JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fed conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Group 4: JNJ-64417184EXPERIMENTALParticipants will receive JNJ-64417184 600 mg tablet under fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fed conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Group 5: JNJ-64417184EXPERIMENTALParticipants will receive JNJ-64417184 600 mg tablet under fed conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Group 6: JNJ-64417184EXPERIMENTALParticipants will receive JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg tablet under fed conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.

Interventions

NameTypeDescription
JNJ-64417184 600 (Oral Tablet Formulation)DRUGParticipants will receive 600 mg of JNJ-64417184 as oral tablet.
JNJ-64417184 (Oral Suspension Formulation)DRUGParticipants will also receive JNJ-64417184 600 mg as oral suspension.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropria...

Countries:United States
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Frequently asked questions about JNJ-64417184 600

What is JNJ-64417184 600?

JNJ-64417184 600 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied to assess its relative oral bioavailability and the effect of food on its absorption.

What does JNJ-64417184 600 target?

The molecular target of JNJ-64417184 600 has not been disclosed in available clinical trial information. The drug is a small molecule, but its specific mechanism of action is not publicly detailed in the current development data.

Who makes JNJ-64417184 600?

JNJ-64417184 600 is developed by Johnson & Johnson, a multinational pharmaceutical company traded on the NYSE under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.

What phase is JNJ-64417184 600 in?

JNJ-64417184 600 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is JNJ-64417184 600 in?

JNJ-64417184 600 has one completed clinical trial, NCT03952507, titled 'A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants.' This Phase 1 study enrolled 18 healthy adults in the United States and was controlled but not double-blinded.

Is JNJ-64417184 600 the same as JNJ-64417184?

JNJ-64417184 600 is a specific dosage form or strength of the investigational drug JNJ-64417184. The clinical trial NCT03952507 refers to the drug as JNJ-64417184, and the '600' designation likely indicates a 600 mg dose or formulation being studied.