A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants

NCT ID: NCT04090086

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2019-12-10

Brief Summary

The purpose of this study is to evaluate the effect of single and multiple dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and multiple-dose (once daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when coadministered to healthy adult participants under fed conditions.

Conditions

Healthy

Study Design

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

Study Groups

Treatment Sequence 1: Treatment ABC

Participants will receive Treatment A (JNJ-53718678 once daily for 7 days) in Treatment Period 1, followed by Treatment B (JNJ-64417184 once daily for 7 days) in Treatment Period 2, followed by Treatment C (JNJ-53718678 once daily + JNJ-64417184 once daily for 7 days) in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

JNJ-64417184

Intervention Type: DRUG

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Treatment Sequence 2: Treatment BCA

Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

JNJ-64417184

Intervention Type: DRUG

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Treatment Sequence 3: Treatment CAB

Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

JNJ-64417184

Intervention Type: DRUG

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Treatment Sequence 4: Treatment ACB

Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

JNJ-64417184

Intervention Type: DRUG

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Treatment Sequence 5: Treatment BAC

Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

JNJ-64417184

Intervention Type: DRUG

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Treatment Sequence 6: Treatment CBA

Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

JNJ-64417184

Intervention Type: DRUG

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Interventions

JNJ-53718678

JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.

Intervention Type: DRUG

JNJ-64417184

JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, and body weight not less than (<) 50 kg at screening
• Healthy on the basis of physical examination (including skin examination), medical and surgical history, and vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], and pulse rate [after the participant is supine for at least 5 minutes], respiratory rate, and tympanic body temperature) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, extremes included, and no higher than 90 mmHg diastolic at screening
• A normal 12-lead electrocardiogram (ECG; based on mean value of triplicate ECG parameters) at screening, consistent with normal cardiac conduction and function, including: (a) normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); (b) QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (<=) 450 milliseconds (ms) for male participants and <=470 ms for female participants; (c) QRS interval <120 ms; (d) PR interval <=200 ms
• Female participant must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening and on Day -1 of each treatment period

Exclusion Criteria

• History of, or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (calculated creatinine clearance/estimated glomerular filtration rate [eGFR] <60 milliliter per minute (mL/min) at screening, calculated by the modification of diet in renal disease [MDRD] formula), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• 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)
• Any evidence of heart block or bundle branch block at screening
• History of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or tests positive for HIV-1 or HIV-2 at screening
• Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria

• 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 Onderzoekscentrum Groningen, locatie Martini

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2019-002695-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64417184RSV1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108693

Identifier Type: -

Identifier Source: org_study_id