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CompletedNCT03952507Updated Feb 3, 2025

A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants

A Phase 1 interventional study of JNJ-64417184 600 (Oral Tablet Formulation) and JNJ-64417184 (Oral Suspension Formulation) in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Jun 2019, 7 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The main purpose of this study is to evaluate the relative bioavailability of JNJ-64417184, formulated as a test formulation (tablet) compared to a reference formulation (suspension), administered orally in a fasted state, in healthy participants.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.

Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Healthy on the basis of clinical laboratory tests performed at screening. If the results of the hematology, biochemistry, blood coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF) less than or equal to (\<=) 450 milli second (ms) for male participants and \<=470 ms for female participants; QRS interval less than (\<) 120 ms; PR interval \<=200 ms. If the results of the ECG are outside the normal ranges, the participant may be included only if the investigator judges the deviations from normal ECG to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening and on Days -1, 7, and 14 (except for postmenopausal female participants)
  • Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after the last study drug intake

Exclusion criteria

Exclusion Criteria:

  • Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
  • Current human immunodeficiency virus (HIV)-type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
  • History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
  • A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
  • Known allergies, hypersensitivity, or intolerance to JNJ-64417184 or any of its excipients
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Group 1: JNJ-64417184

    Participants 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.

    Drug: JNJ-64417184 600 (Oral Tablet Formulation) · Drug: JNJ-64417184 (Oral Suspension Formulation)

  • Experimental
    Group 2: JNJ-64417184

    Participants 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.

    Drug: JNJ-64417184 600 (Oral Tablet Formulation) · Drug: JNJ-64417184 (Oral Suspension Formulation)

  • Experimental
    Group 3: JNJ-64417184

    Participants 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.

    Drug: JNJ-64417184 600 (Oral Tablet Formulation) · Drug: JNJ-64417184 (Oral Suspension Formulation)

  • Experimental
    Group 4: JNJ-64417184

    Participants 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.

    Drug: JNJ-64417184 600 (Oral Tablet Formulation) · Drug: JNJ-64417184 (Oral Suspension Formulation)

  • Experimental
    Group 5: JNJ-64417184

    Participants 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.

    Drug: JNJ-64417184 600 (Oral Tablet Formulation) · Drug: JNJ-64417184 (Oral Suspension Formulation)

  • Experimental
    Group 6: JNJ-64417184

    Participants 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.

    Drug: JNJ-64417184 600 (Oral Tablet Formulation) · Drug: JNJ-64417184 (Oral Suspension Formulation)

Interventions

06

What researchers measure

Primary outcomes

  1. Relative Bioavailability of JNJ-64417184

    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.

    Time frame: 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

Secondary outcomes

  1. Plasma Concentration of JNJ-64417184 in Fasted Conditions

    Plasma concentration of JNJ-64417184 will be determined when administered as suspension under fasted conditions.

    Time frame: 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

  2. Plasma Concentration of JNJ-64417184 in fed and Fasted Conditions

    Plasma concentration of JNJ-64417184 will be determined when administered as tablet under fed and fasted conditions.

    Time frame: 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

  3. Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in fed State

    Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fed state.

    Time frame: 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

  4. Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last Quantifiable Concentration (AUC [0-last]) in fed State

    AUC (0-last) is defined as area under the plasma analyte concentration- time curve (AUC) from time 0 to time of the last quantifiable concentration of JNJ-64417184 in fed state.

    Time frame: 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

  5. Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in fed State

    AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to infinite time of JNJ-64417184 in fed state.

    Time frame: 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

  6. Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in Fasted State

    Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fasted state.

    Time frame: 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

  7. Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last (AUC [0-last]) Quantifiable Concentration in Fasted State

    AUC (0-last) is defined as area under the plasma analyte concentration- time curve (AUC) from time 0 to time of the last quantifiable concentration of JNJ-64417184 in fasted state.

    Time frame: 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

  8. Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in Fasted State

    AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to infinite time of JNJ-64417184 in fasted state.

    Time frame: 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

  9. Number of Participants with Adverse Event as Measure of Safety and Tolerability

    An adverse event 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.

    Time frame: Approximately 21 Days

07

Study locations

1 site
  • PRA Health Sciences Salt Lake City Clinic
    Salt Lake City, Utah 84124, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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

Data sharing details ↗ · www.janssen.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03952507
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
May 16, 2019
Start date
May 15, 2019
Primary completion
Jun 22, 2019
Completion
Jun 22, 2019
Last update
Feb 3, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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