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

NCT ID: NCT03952507

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2019-06-22

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-64417184 600 (Oral Tablet Formulation)

Intervention Type: DRUG

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

JNJ-64417184 (Oral Suspension Formulation)

Intervention Type: DRUG

Participants will also receive JNJ-64417184 600 mg as oral suspension.

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.

Group Type: EXPERIMENTAL

JNJ-64417184 600 (Oral Tablet Formulation)

Intervention Type: DRUG

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

JNJ-64417184 (Oral Suspension Formulation)

Intervention Type: DRUG

Participants will also receive JNJ-64417184 600 mg as oral suspension.

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.

Group Type: EXPERIMENTAL

JNJ-64417184 600 (Oral Tablet Formulation)

Intervention Type: DRUG

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

JNJ-64417184 (Oral Suspension Formulation)

Intervention Type: DRUG

Participants will also receive JNJ-64417184 600 mg as oral suspension.

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.

Group Type: EXPERIMENTAL

JNJ-64417184 600 (Oral Tablet Formulation)

Intervention Type: DRUG

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

JNJ-64417184 (Oral Suspension Formulation)

Intervention Type: DRUG

Participants will also receive JNJ-64417184 600 mg as oral suspension.

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.

Group Type: EXPERIMENTAL

JNJ-64417184 600 (Oral Tablet Formulation)

Intervention Type: DRUG

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

JNJ-64417184 (Oral Suspension Formulation)

Intervention Type: DRUG

Participants will also receive JNJ-64417184 600 mg as oral suspension.

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.

Group Type: EXPERIMENTAL

JNJ-64417184 600 (Oral Tablet Formulation)

Intervention Type: DRUG

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

JNJ-64417184 (Oral Suspension Formulation)

Intervention Type: DRUG

Participants will also receive JNJ-64417184 600 mg as oral suspension.

Interventions

JNJ-64417184 600 (Oral Tablet Formulation)

Participants will receive 600 mg of JNJ-64417184 as oral tablet.

Intervention Type: DRUG

JNJ-64417184 (Oral Suspension Formulation)

Participants will also receive JNJ-64417184 600 mg as oral suspension.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRA Health Sciences Salt Lake City Clinic

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

64417184RSV1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108632

Identifier Type: -

Identifier Source: org_study_id