A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants

NCT04453189 | Completed Phase 1

• 3 other identifiers: CR1088122020-000380-2364417184RSV1004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the effect of multiple-dose administration of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult participants; and to evaluate the effect of time-separated, multiple-dose administration of famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184

  Cmax is defined as the maximum observed plasma analyte concentration.

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)

• Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-last]) of JNJ-64417184

  AUC(0-last) is defined as the area under the plasma analyte concentration-time curve from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration calculated by linear-linear trapezoidal summation.

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)

• Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-64417184

  Area under the plasma analyte concentration-time curve from time 0 to infinite time, calculated as AUC (0-last) + C (0-last)/lambda(z), where C (0-last) is the last observed measurable (non BQL) plasma analyte concentration; AUC (0-last) is the area under the plasma analyte concentration-time curve from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration and lambda(z) is the terminal phase rate constant. Extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)

Secondary Outcomes (4)

• Number of Participants with Adverse Event as a Measure of Safety and Tolerability

  Up to 2.5 months

• Number of Participants with Clinically Significant Changes in Vital Signs

  Up to 2.5 years

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

  Up to 2.5 years

• Number of Participants with Clinically Significant Abnormalities in Electrocardiogram

  Up to 2.5 years

Study Arms (2)

Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)

EXPERIMENTAL

Participants will received Treatment A (single dose of JNJ-64417184 in fed condition on Day 1) in period 1 followed by Treatment B (lansoprazole on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5) in period 2 of part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.

Drug: JNJ-64417184; Drug: Lansoprazole; Drug: Famotidine

Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)

EXPERIMENTAL

Participants will receive Treatment B in period 1 followed by Treatment A in period 2, Part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.

Drug: JNJ-64417184; Drug: Lansoprazole; Drug: Famotidine

Interventions

JNJ-64417184 DRUG

Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.

Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional); Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)

Lansoprazole DRUG

Participants will receive lansoprazole once daily in fasted condition on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5 in assigned treatment sequence.

Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional); Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)

Famotidine DRUG

Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.

Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional); Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)

Eligibility Criteria

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

You may qualify if:

• Must have a body mass index (BMI) between 18.0 and 30.0 kilograms per square meters \[kg/m\^2\]), extremes included, and body weight not less than 50.0 kilograms (kg) at screening
• Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening
• Healthy on the basis of clinical laboratory tests performed at screening
• 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 milliseconds (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
• Must sign an informed consent form (ICF) indicating he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

You may not qualify if:

• History of liver or renal dysfunction (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), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
• Past history of clinically significant cardiac arrhythmias (for example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
• Any evidence of clinically significant heart block or bundle branch block at screening
• Current human immunodeficiency virus 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 HCV infection (confirmed by hepatitis C virus \[HCV\] antibody) at screening

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

Lansoprazole; Famotidine

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

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: June 29, 2020
• First Posted: July 1, 2020
• Study Start: July 20, 2020
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)