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

NCT04090086 | Completed Phase 1

• 3 other identifiers: CR1086932019-002695-1364417184RSV1003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678

  Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.

  Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

• Ctrough of JNJ-64417184

  Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.

  Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

• Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-53718678

  Cmax is defined as maximum observed plasma analyte concentration.

  Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

• Cmax of JNJ-64417184

  Cmax is defined as maximum observed plasma analyte concentration.

  Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

• Area Under the Plasma Concentration-time Curve from Time of Administration up to 24 Hours Postdose (AUC[24h]) of JNJ-53718678

  AUC24h is defined as AUC from time 0 to 24 hours postdose.

  Up to 24 hours postdose

• AUC24h of JNJ-64417184

  AUC24h is defined as AUC from time 0 to 24 hours postdose.

  Up to 24 hours postdose

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to 42 days

Study Arms (6)

Treatment Sequence 1: Treatment ABC

EXPERIMENTAL

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.

Drug: JNJ-53718678; Drug: JNJ-64417184

Treatment Sequence 2: Treatment BCA

EXPERIMENTAL

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.

Drug: JNJ-53718678; Drug: JNJ-64417184

Treatment Sequence 3: Treatment CAB

EXPERIMENTAL

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.

Drug: JNJ-53718678; Drug: JNJ-64417184

Treatment Sequence 4: Treatment ACB

EXPERIMENTAL

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.

Drug: JNJ-53718678; Drug: JNJ-64417184

Treatment Sequence 5: Treatment BAC

EXPERIMENTAL

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.

Drug: JNJ-53718678; Drug: JNJ-64417184

Treatment Sequence 6: Treatment CBA

EXPERIMENTAL

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.

Drug: JNJ-53718678; Drug: JNJ-64417184

Interventions

JNJ-53718678 DRUG

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

Treatment Sequence 1: Treatment ABC; Treatment Sequence 2: Treatment BCA; Treatment Sequence 3: Treatment CAB; Treatment Sequence 4: Treatment ACB; Treatment Sequence 5: Treatment BAC; Treatment Sequence 6: Treatment CBA

JNJ-64417184 DRUG

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

Treatment Sequence 1: Treatment ABC; Treatment Sequence 2: Treatment BCA; Treatment Sequence 3: Treatment CAB; Treatment Sequence 4: Treatment ACB; Treatment Sequence 5: Treatment BAC; Treatment Sequence 6: Treatment CBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

JNJ-53718678

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: September 16, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)