HealthyPhase 1NCT02951845
Study to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076 in Healthy Participants
A Phase 1 study testing JNJ-54416076 (Oral Suspension), JNJ-54416076 (Formulation 1: Direct Compression Tablets) and JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy 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-54416076 (Oral Suspension), JNJ-54416076 (Formulation 1: Direct Compression Tablets) and JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to 17 Feb 2017
- 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
- Before randomization, a woman must be: 1) Postmenopausal, defined as a) Greater than (>) 45 years of age with amenorrhea for greater than or equal to (>=)18 months, or b) > 45 years of age with amenorrhea for at least 6 months and lesser than (<)18 months and a serum follicle stimulating hormone (FSH) level >40 International units per liter (IU/L), or 2) Surgically sterile due to a hysterectomy, or bilateral oophorectomy, or bilateral tubal occlusion/ligation procedures, and 3) All women must have a negative serum pregnancy test at Screening; and on Day -1 at each treatment period
- Men (including those who have had vasectomies) must agree to use condoms even if their partner is pregnant (this is to ensure that the fetus is not exposed to the study drug through vaginal absorption) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Male participants should encourage their female partner to use an effective method (for example (eg), prescription oral contraceptives, contraceptive injections, intrauterine device, and contraceptive patch) of contraception in addition to the condom used by the male study participant
- Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiograms (ECGs) performed. If any of the results are abnormal, the participant may be included only if the investigator judges that the abnormalities or deviations from normal are not clinically significant except for liver function and hematology tests. This determination must be recorded in the participant's source documents and initialed by the investigator
- Body Mass Index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)(inclusive) and body weight >= 50 kilograms
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive at Screening and on Days -2 and -1 of Period 1. If blood pressure is out of range, up to 2 repeated assessments are permitted
Who cannot join
- History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (eg, hyper/hypo-thyroidism), hematological disease (eg, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, renal disorder, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- History of Gilbert's disease, Dubin-Johnson or Rotor syndrome, or any family history of liver or gallbladder disease that may suggest an underlying genetic disorder
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), bilirubin levels (indirect, or direct), or alkaline phosphatase above the upper limit of normal (ULN) of the clinical laboratory's reference range at Screening or at Day -1 of Period 1
- Hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the clinical laboratory's reference range at Screening. On Day -1 of Period 1, if participants have hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the laboratory's reference range, the participants may be included if the investigator judges that the abnormalities or deviations from the reference are not clinically significant
- History of cholecystectomy or gallbladder disease
- Known allergies, hypersensitivity, or intolerance to any of the excipients of the formulation
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Open-Label, Single Dose, Randomized, Three-Way Crossover Study In Healthy Subjects to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076
The purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.
- Conditions
- Healthy
- Being tested
- JNJ-54416076 (Oral Suspension), JNJ-54416076 (Formulation 1: Direct Compression Tablets), JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54416076 (Oral Suspension)Drug
Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2.
JNJ-54416076 (Formulation 1: Direct Compression Tablets)Drug
Participants will receive JNJ-54416076 Tablet formulation 1 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 1.
JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Drug
Participants will receive JNJ-54416076 Tablet formulation 2 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 2.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment Sequence A1B1C1 | Experimental | Participants in Part 1 will only receive single dose of Treatment A1 oral Suspension (25 milligram [mg], Fasted) then Treatment B1 (Direct Compression Tablets, 5*5 mg Tablets, Fasted) followed by Treatment C1 (Direct Compression Tablets (5*5 mg Tablets, Fed) on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets) |
| Part 1: Treatment Sequence B1C1A1 | Experimental | Participants in Part 1 will only receive single dose of Treatment B1 then Treatment C1 followed by Treatment A1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets) |
| Part 1: Treatment Sequence C1A1B1 | Experimental | Participants in Part 1 will only receive single dose of Treatment C1 then Treatment A1 followed by Treatment B1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets) |
| Part 1: Treatment Sequence A1C1B1 | Experimental | Participants in Part 1 will only receive single dose of Treatment A1 then Treatment C1 followed by Treatment B1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets) |
| Part 1: Treatment Sequence B1A1C1 | Experimental | Participants in Part 1 will only receive single dose of Treatment B1 then Treatment A1 followed by Treatment C1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets) |
| Part 1: Treatment Sequence C1B1A1 | Experimental | Participants in Part 1 will only receive single dose of Treatment C1 then Treatment B1 followed by Treatment A1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets) |
| Part 2: Treatment Sequence A2B2C2 | Experimental | Participants in Part 2 will only receive single dose of Treatment A2 oral Suspension (25 mg, Fasted) then Treatment B2 (Fluid Bed Granulation Tablets (5*5 mg Tablets, Fasted) followed by Treatment C2 (Fluid Bed Granulation Tablets, 5*5 mg Tablets, Fed) on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) |
| Part 2: Treatment Sequence B2C2A2 | Experimental | Participants in Part 2 will only receive single dose of Treatment B2 then Treatment C2 followed by Treatment A2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) |
| Part 2: Treatment Sequence C2A2B2 | Experimental | Participants in Part 2 will only receive single dose of Treatment C2 then Treatment A2 followed by Treatment B2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) |
| Part 2: Treatment Sequence A2C2B2 | Experimental | Participants in Part 2 will only receive single dose of Treatment A2 then Treatment C2 followed by Treatment B2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) |
| Part 2: Treatment Sequence B2A2C2 | Experimental | Participants in Part 2 will only receive single dose of Treatment B2 then Treatment A2 followed by Treatment C2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) |
| Part 2: Treatment Sequence C2B2A2 | Experimental | Participants in Part 2 will only receive single dose of Treatment C2 then Treatment B2 followed by Treatment A2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). Receives: Drug: JNJ-54416076 (Oral Suspension); Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Analyte Concentration (Cmax)
Cmax is the maximum observed analyte concentration.
Measured: Predose up to Day 4
Time to Reach Maximum Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Predose up to Day 4
Area Under Concentration Curve from time zero to the last quantifiable (AUC [0-last])
Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear trapezoidal summation.
Measured: Predose up to Day 4
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Measured: Predose up to Day 4
Apparent Terminal Elimination Half-life (t1/2term)
The elimination halflife (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).
Measured: Predose up to Day 4
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: 5 to 7 days after discharge (Follow-Up Phase )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start22 Nov 2016
- Primary completion17 Feb 2017 (estimated)
- Study completion17 Feb 2017 (estimated)
Why it stopped: JNJ-54416076 program has been stopped for strategic business reasons.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02951845
- Sponsor's protocol ID
- CR108239
- Other IDs
- 54416076EDI1002
- Status last verified
- Jan 2025
- First submitted
- 31 Oct 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
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
- An Exploratory Open-Label, Single Dose, Randomized, Three-Way Crossover Study In Healthy Subjects to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076
- ClinicalTrials.gov ID
- NCT02951845
- Acronym / sponsor ID
- CR108239
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: JNJ-54416076 program has been stopped for strategic business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 17 Feb 2017 (estimated)
- Study completion
- 17 Feb 2017 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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 purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part 1: Treatment Sequence A1B1C1 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants in Part 1 will only receive single dose of Treatment A1 oral Suspension (25 milligram [mg], Fasted) then Treatment B1 (Direct Compression Tablets, 5*5 mg Tablets, Fasted) followed by Treatment C1 (Direct Compression Tablets (5*5 mg Tablets, Fed) on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 1: Treatment Sequence B1C1A1 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants in Part 1 will only receive single dose of Treatment B1 then Treatment C1 followed by Treatment A1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 1: Treatment Sequence C1A1B1 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants in Part 1 will only receive single dose of Treatment C1 then Treatment A1 followed by Treatment B1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 1: Treatment Sequence A1C1B1 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants in Part 1 will only receive single dose of Treatment A1 then Treatment C1 followed by Treatment B1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 1: Treatment Sequence B1A1C1 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants in Part 1 will only receive single dose of Treatment B1 then Treatment A1 followed by Treatment C1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 1: Treatment Sequence C1B1A1 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants in Part 1 will only receive single dose of Treatment C1 then Treatment B1 followed by Treatment A1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 2: Treatment Sequence A2B2C2 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants in Part 2 will only receive single dose of Treatment A2 oral Suspension (25 mg, Fasted) then Treatment B2 (Fluid Bed Granulation Tablets (5*5 mg Tablets, Fasted) followed by Treatment C2 (Fluid Bed Granulation Tablets, 5*5 mg Tablets, Fed) on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 2: Treatment Sequence B2C2A2 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants in Part 2 will only receive single dose of Treatment B2 then Treatment C2 followed by Treatment A2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 2: Treatment Sequence C2A2B2 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants in Part 2 will only receive single dose of Treatment C2 then Treatment A2 followed by Treatment B2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 2: Treatment Sequence A2C2B2 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants in Part 2 will only receive single dose of Treatment A2 then Treatment C2 followed by Treatment B2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 2: Treatment Sequence B2A2C2 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants in Part 2 will only receive single dose of Treatment B2 then Treatment A2 followed by Treatment C2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Part 2: Treatment Sequence C2B2A2 | Experimental | Drug: JNJ-54416076 (Oral Suspension), Drug: JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants in Part 2 will only receive single dose of Treatment C2 then Treatment B2 followed by Treatment A2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Before randomization, a woman must be: 1) Postmenopausal, defined as a) Greater than (>) 45 years of age with amenorrhea for greater than or equal to (>=)18 months, or b) > 45 years of age with amenorrhea for at least 6 months and lesser than (<)18 months and a serum follicle stimulating hormone (FSH) level >40 International units per liter (IU/L), or 2) Surgically sterile due to a hysterectomy, or bilateral oophorectomy, or bilateral tubal occlusion/ligation procedures, and 3) All women must have a negative serum pregnancy test at Screening; and on Day -1 at each treatment period
- Men (including those who have had vasectomies) must agree to use condoms even if their partner is pregnant (this is to ensure that the fetus is not exposed to the study drug through vaginal absorption) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Male participants should encourage their female partner to use an effective method (for example (eg), prescription oral contraceptives, contraceptive injections, intrauterine device, and contraceptive patch) of contraception in addition to the condom used by the male study participant
- Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiograms (ECGs) performed. If any of the results are abnormal, the participant may be included only if the investigator judges that the abnormalities or deviations from normal are not clinically significant except for liver function and hematology tests. This determination must be recorded in the participant's source documents and initialed by the investigator
- Body Mass Index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)(inclusive) and body weight >= 50 kilograms
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive at Screening and on Days -2 and -1 of Period 1. If blood pressure is out of range, up to 2 repeated assessments are permitted
Key exclusion criteria (7 listed)
- History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (eg, hyper/hypo-thyroidism), hematological disease (eg, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, renal disorder, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- History of Gilbert's disease, Dubin-Johnson or Rotor syndrome, or any family history of liver or gallbladder disease that may suggest an underlying genetic disorder
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), bilirubin levels (indirect, or direct), or alkaline phosphatase above the upper limit of normal (ULN) of the clinical laboratory's reference range at Screening or at Day -1 of Period 1
- Hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the clinical laboratory's reference range at Screening. On Day -1 of Period 1, if participants have hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the laboratory's reference range, the participants may be included if the investigator judges that the abnormalities or deviations from the reference are not clinically significant
- History of cholecystectomy or gallbladder disease
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-54416076 (Oral Suspension)Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2. | Drug | Part 1: Treatment Sequence A1B1C1, Part 1: Treatment Sequence A1C1B1, Part 1: Treatment Sequence B1A1C1, Part 1: Treatment Sequence B1C1A1, Part 1: Treatment Sequence C1A1B1, Part 1: Treatment Sequence C1B1A1, Part 2: Treatment Sequence A2B2C2, Part 2: Treatment Sequence A2C2B2, Part 2: Treatment Sequence B2A2C2, Part 2: Treatment Sequence B2C2A2, Part 2: Treatment Sequence C2A2B2, Part 2: Treatment Sequence C2B2A2 |
| JNJ-54416076 (Formulation 1: Direct Compression Tablets)Participants will receive JNJ-54416076 Tablet formulation 1 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 1. | Drug | Part 1: Treatment Sequence A1B1C1, Part 1: Treatment Sequence A1C1B1, Part 1: Treatment Sequence B1A1C1, Part 1: Treatment Sequence B1C1A1, Part 1: Treatment Sequence C1A1B1, Part 1: Treatment Sequence C1B1A1 |
| JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)Participants will receive JNJ-54416076 Tablet formulation 2 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 2. | Drug | Part 2: Treatment Sequence A2B2C2, Part 2: Treatment Sequence A2C2B2, Part 2: Treatment Sequence B2A2C2, Part 2: Treatment Sequence B2C2A2, Part 2: Treatment Sequence C2A2B2, Part 2: Treatment Sequence C2B2A2 |
Primary outcome
Maximum Observed Analyte Concentration (Cmax)
Time frame: Predose up to Day 4
Cmax is the maximum observed analyte concentration.
Time to Reach Maximum Concentration (Tmax)
Time frame: Predose up to Day 4
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under Concentration Curve from time zero to the last quantifiable (AUC [0-last])
Time frame: Predose up to Day 4
Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear trapezoidal summation.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Predose up to Day 4
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Apparent Terminal Elimination Half-life (t1/2term)
Time frame: Predose up to Day 4
The elimination halflife (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 5 to 7 days after discharge (Follow-Up Phase )
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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-54416076 (Oral Suspension), JNJ-54416076 (Formulation 1: Direct Compression Tablets) and JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 7 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: withdrawn, 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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 Analyte Concentration (Cmax) (time frame: Predose up to Day 4). The study lists 5 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.