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Healthy ParticipantsPhase 1NCT04453189

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

A Phase 1 study testing JNJ-64417184, Lansoprazole and Famotidine in people with Healthy Participants, run by Janssen Research & Development, LLC at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
JNJ-64417184, Lansoprazole and Famotidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteNetherlands
Study dates
20 Jul 2020to 14 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase 1, Open-label, Randomized, 2-Way Crossover Study to Assess the Effects of Acid-Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of JNJ-64417184 in Healthy Adult Participants

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).

Being tested
JNJ-64417184, Lansoprazole, Famotidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64417184Drug

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

  • LansoprazoleDrug

    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.

  • FamotidineDrug

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

Study groups in NCT04453189
Study groupRoleWhat they receive
Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)ExperimentalParticipants 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.
Receives: Drug: JNJ-64417184; Drug: Lansoprazole; Drug: Famotidine
Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)ExperimentalParticipants 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.
Receives: Drug: JNJ-64417184; Drug: Lansoprazole; Drug: Famotidine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Cmax is defined as the maximum observed plasma analyte concentration.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

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

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.

    Measured: Up to 2.5 months

  2. Number of Participants with Clinically Significant Changes in Vital Signs

    Number of participants with clinically significant abnormalities in vital signs (Systolic and diastolic blood pressure and pulse rate) will be assessed.

    Measured: Up to 2.5 years

  3. Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

    Number of participants with clinically significant abnormalities in laboratory parameters (Hematology Panel, biochemistry panel, coagulation and urinalysis) will be assessed.

    Measured: Up to 2.5 years

  4. Number of Participants with Clinically Significant Abnormalities in Electrocardiogram

    Number of participants with clinically significant abnormalities in electrocardiogram will be assessed.

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start20 Jul 2020
  3. Primary completion14 Sep 2020
  4. Study completion14 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453189
Sponsor's protocol ID
CR108812
Other IDs
2020-000380-23, 64417184RSV1004
Status last verified
Jan 2025
First submitted
29 Jun 2020
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64417184, Lansoprazole and Famotidine in people with Healthy Participants, run by Janssen Research & Development, LLC at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04453189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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