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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-64417184 600 (Oral Tablet Formulation); Drug: JNJ-64417184 (Oral Suspension Formulation)

• Registration Number: NCT03952507
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Primary Completion: 2019-06-22
• Study Completion: 2019-06-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2: JNJ-64417184	JNJ-64417184 (Oral Suspension Formulation)	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.
Group 5: JNJ-64417184	JNJ-64417184 600 (Oral Tablet Formulation)	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.
Group 6: JNJ-64417184	JNJ-64417184 (Oral Suspension Formulation)	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.
Group 4: JNJ-64417184	JNJ-64417184 (Oral Suspension Formulation)	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.
Group 3: JNJ-64417184	JNJ-64417184 600 (Oral Tablet Formulation)	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.
Group 4: JNJ-64417184	JNJ-64417184 600 (Oral Tablet Formulation)	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.
Group 5: JNJ-64417184	JNJ-64417184 (Oral Suspension Formulation)	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.
Group 1: JNJ-64417184	JNJ-64417184 600 (Oral Tablet Formulation)	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.
Group 1: JNJ-64417184	JNJ-64417184 (Oral Suspension Formulation)	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.
Group 6: JNJ-64417184	JNJ-64417184 600 (Oral Tablet Formulation)	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.
Group 2: JNJ-64417184	JNJ-64417184 600 (Oral Tablet Formulation)	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.
Group 3: JNJ-64417184	JNJ-64417184 (Oral Suspension Formulation)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 will be determined when administered as suspension under fasted conditions.
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	Plasma concentration of JNJ-64417184 will be determined when administered as tablet under fed and fasted conditions.
Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last (AUC [0-last]) Quantifiable Concentration in Fasted 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	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.
Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in Fasted 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	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.
Number of Participants with Adverse Event as Measure of Safety and Tolerability	Approximately 21 Days	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.
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	Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fed state.
Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last Quantifiable Concentration (AUC [0-last]) 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	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.
Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) 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	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.
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in Fasted 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	Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fasted state.

Trial Locations

Locations (1)

PRA Health Sciences Salt Lake City Clinic; 🇺🇸 Salt Lake City, Utah, United States