A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants
NCT ID: NCT04453189
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2020-07-20
2020-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)
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.
JNJ-64417184
Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.
Lansoprazole
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.
Famotidine
Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.
Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)
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.
JNJ-64417184
Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.
Lansoprazole
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.
Famotidine
Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.
Interventions
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JNJ-64417184
Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.
Lansoprazole
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.
Famotidine
Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, , Netherlands
Countries
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Other Identifiers
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2020-000380-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64417184RSV1004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108812
Identifier Type: -
Identifier Source: org_study_id
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