HealthyPhase 1NCT04208373
A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants
A Phase 1 study testing JNJ-64417184, Itraconazole and Etravirine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The main purpose of this study is to evaluate the effects of itraconazole or etravirine on the single-dose pharmacokinetics (PK) of JNJ 64417184 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64417184, Itraconazole and Etravirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2019to 10 Mar 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
- Body mass index (weight [kg]/height2 [m]2) between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50 kg at screening
- Healthy on the basis of physical examination, medical and surgical history, and vital signs (systolic blood pressure, diastolic blood pressure, and pulse rate [after the participant is supine for at least 5 minutes], respiratory rate, and oral 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 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
- Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1
- Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after the last study drug intake
- Must not use nicotine-containing substances including tobacco products (example, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least 3 months prior to screening
Who cannot join
- History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) less than (<) 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 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
- Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening
- History of hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody at screening
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerp, 2060
About this study
Official title: A Phase 1, Open-label, Fixed-sequence, 2-Panel Study to Assess the Effects of Itraconazole and Etravirine on the Single-dose Pharmacokinetics of JNJ-64417184 in Healthy Adult Subjects
The main purpose of this study is to evaluate the effects of itraconazole or etravirine on the single-dose pharmacokinetics (PK) of JNJ 64417184 in healthy adult participants.
- Conditions
- Healthy
- Being tested
- JNJ-64417184, Itraconazole, Etravirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64417184Drug
JNJ 64417184 tablets will be administered orally.
ItraconazoleDrug
Itraconazole capsules will be administered orally
EtravirineDrug
etravirine tables will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: JNJ 64417184 plus Itraconazole | Experimental | Participants will receive single oral dose of JNJ 64417184 on Day 1 followed by itraconazole once daily on Days 6 to 13 along with a single dose of JNJ 64417184 on Day 9 orally. Receives: Drug: JNJ-64417184; Drug: Itraconazole |
| Panel 2: JNJ 64417184 plus Etravirine | Experimental | Participants will receive single oral dose of JNJ-64417184 on Day 1 followed by etravirine twice daily on Days 6 to 19 along with single dose of JNJ 64417184 on Day 15. Receives: Drug: JNJ-64417184; Drug: Etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184
Cmax is defined as maximum observed plasma analyte.
Measured: Predose up to 144 hours post dose
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ 64417184
AUC (0-last) is defined as the area under the plasma analyte concentration- time curve (AUC) from time 0 to the time of the last measurable (non-below qualification limit) concentration.
Measured: Predose up to 144 hours post dose
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ 64417184
AUC (0-infinity) is defined as AUC from time 0 to infinite time, calculated as the sum of AUC(0-last) and C(last)/ lambda(z), wherein C(last) is the last observed quantifiable concentration; extrapolations of more than 20 percent (%) of the total AUC.
Measured: Predose up to 144 hours post dose
Secondary outcomes (1)
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 54 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start20 Dec 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208373
- Sponsor's protocol ID
- CR108747
- Other IDs
- 2019-003928-20, 64417184RSV1002, 2019
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2019
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed-sequence, 2-Panel Study to Assess the Effects of Itraconazole and Etravirine on the Single-dose Pharmacokinetics of JNJ-64417184 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04208373
- Acronym / sponsor ID
- CR108747
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the effects of itraconazole or etravirine on the single-dose pharmacokinetics (PK) of JNJ 64417184 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panel 1: JNJ 64417184 plus Itraconazole | Experimental | Drug: JNJ-64417184, Drug: ItraconazoleParticipants will receive single oral dose of JNJ 64417184 on Day 1 followed by itraconazole once daily on Days 6 to 13 along with a single dose of JNJ 64417184 on Day 9 orally. |
| Panel 2: JNJ 64417184 plus Etravirine | Experimental | Drug: JNJ-64417184, Drug: EtravirineParticipants will receive single oral dose of JNJ-64417184 on Day 1 followed by etravirine twice daily on Days 6 to 19 along with single dose of JNJ 64417184 on Day 15. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (weight [kg]/height2 [m]2) between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50 kg at screening
- Healthy on the basis of physical examination, medical and surgical history, and vital signs (systolic blood pressure, diastolic blood pressure, and pulse rate [after the participant is supine for at least 5 minutes], respiratory rate, and oral 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 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
- Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1
- Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after the last study drug intake
- Must not use nicotine-containing substances including tobacco products (example, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least 3 months prior to screening
Key exclusion criteria (5 listed)
- History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) less than (<) 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 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
- Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening
- History of hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-64417184JNJ 64417184 tablets will be administered orally. | Drug | Panel 1: JNJ 64417184 plus Itraconazole, Panel 2: JNJ 64417184 plus Etravirine |
| ItraconazoleItraconazole capsules will be administered orally | Drug | Panel 1: JNJ 64417184 plus Itraconazole |
| Etravirineetravirine tables will be administered orally. | Drug | Panel 2: JNJ 64417184 plus Etravirine |
Primary outcome
Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184
Time frame: Predose up to 144 hours post dose
Cmax is defined as maximum observed plasma analyte.
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ 64417184
Time frame: Predose up to 144 hours post dose
AUC (0-last) is defined as the area under the plasma analyte concentration- time curve (AUC) from time 0 to the time of the last measurable (non-below qualification limit) concentration.
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ 64417184
Time frame: Predose up to 144 hours post dose
AUC (0-infinity) is defined as AUC from time 0 to infinite time, calculated as the sum of AUC(0-last) and C(last)/ lambda(z), wherein C(last) is the last observed quantifiable concentration; extrapolations of more than 20 percent (%) of the total AUC.
1 secondary outcome
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to 54 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: 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
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64417184, Itraconazole and Etravirine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 Belgium. 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 up to 144 hours post dose). 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?
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.