HealthyPhase 1NCT02930694
A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants
A Phase 1 study testing JNJ-54175446 (capsule) and JNJ-54175446 (suspension) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The primary purpose of the study is to investigate the plasma pharmacokinetics and bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of JNJ-54175446 under fasting conditions. 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-54175446 (capsule) and JNJ-54175446 (suspension)
- 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 siteUnited States
- Study dates
- Oct 2016to Dec 2016
- 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
- A body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height^2)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) [inclusive QTcF less than or equal to (<=) 450 millisecond (msec) for males and <= 470 msec for females] performed at screening and admission (Treatment period 1) to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the physician investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
- Healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel [excluding liver function tests], hematology [including coagulation], or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed/signed by the physician investigator
- Must be willing to adhere to the prohibitions and restrictions specified in this protocol
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- History of or current liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
- History of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (latest edition DSM-5) criteria within 6 months before Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, 2-Way Crossover, Parallel-group Study in Healthy Male and Female Subjects to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446
The primary purpose of the study is to investigate the plasma pharmacokinetics and bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of JNJ-54175446 under fasting conditions.
- Conditions
- Healthy
- Being tested
- JNJ-54175446 (capsule), JNJ-54175446 (suspension)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54175446 (capsule)Drug
Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)Drug
Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Treatment Sequence AB | Experimental | Participants will receive Treatment A [JNJ-54175446, 50 milligram (mg) capsule] on Day 1 of period 1 followed by Treatment B [JNJ-54175446, 50 mg suspension] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. Receives: Drug: JNJ-54175446 (capsule); Drug: JNJ-54175446 (suspension) |
| Group 1: Treatment Sequence BA | Experimental | Participants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. Receives: Drug: JNJ-54175446 (capsule); Drug: JNJ-54175446 (suspension) |
| Group 2: Treatment Sequence CD | Experimental | Participants will receive Treatment C [JNJ-54175446, 100 mg capsule] on Day 1 of period 1 followed by Treatment D [JNJ-54175446, 100 mg suspension] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. Receives: Drug: JNJ-54175446 (capsule); Drug: JNJ-54175446 (suspension) |
| Group 2: Treatment Sequence DC | Experimental | Participants will receive Treatment D on Day 1 of period 1 followed by Treatment C on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. Receives: Drug: JNJ-54175446 (capsule); Drug: JNJ-54175446 (suspension) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of JNJ-54175446
The Cmax is the maximum observed plasma concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-54175446
The Tmax is defined as actual sampling time to reach maximum plasma concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of JNJ-54175446
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-54175446
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(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Elimination Rate Constant (Lambda[z]) of JNJ-54175446
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Elimination Half-Life (t1/2) of JNJ-54175446
The elimination half-life (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 is calculated as 0.693/lambda(z).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Relative Bioavailability of JNJ-54175446
Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of capsule to suspension formulation).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Baseline up to 9 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionDec 2016
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
- Other
- Allocation
- 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
- NCT02930694
- Sponsor's protocol ID
- CR108246
- Other IDs
- 54175446EDI1003
- Status last verified
- Feb 2017
- First submitted
- 10 Oct 2016
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2-Way Crossover, Parallel-group Study in Healthy Male and Female Subjects to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446
- ClinicalTrials.gov ID
- NCT02930694
- Acronym / sponsor ID
- CR108246
- 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
- Oct 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Oct 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 primary purpose of the study is to investigate the plasma pharmacokinetics and bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of JNJ-54175446 under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Treatment Sequence AB | Experimental | Drug: JNJ-54175446 (capsule), Drug: JNJ-54175446 (suspension)Participants will receive Treatment A [JNJ-54175446, 50 milligram (mg) capsule] on Day 1 of period 1 followed by Treatment B [JNJ-54175446, 50 mg suspension] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
| Group 1: Treatment Sequence BA | Experimental | Drug: JNJ-54175446 (capsule), Drug: JNJ-54175446 (suspension)Participants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
| Group 2: Treatment Sequence CD | Experimental | Drug: JNJ-54175446 (capsule), Drug: JNJ-54175446 (suspension)Participants will receive Treatment C [JNJ-54175446, 100 mg capsule] on Day 1 of period 1 followed by Treatment D [JNJ-54175446, 100 mg suspension] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
| Group 2: Treatment Sequence DC | Experimental | Drug: JNJ-54175446 (capsule), Drug: JNJ-54175446 (suspension)Participants will receive Treatment D on Day 1 of period 1 followed by Treatment C on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height^2)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) [inclusive QTcF less than or equal to (<=) 450 millisecond (msec) for males and <= 470 msec for females] performed at screening and admission (Treatment period 1) to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the physician investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
- Healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel [excluding liver function tests], hematology [including coagulation], or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed/signed by the physician investigator
- Must be willing to adhere to the prohibitions and restrictions specified in this protocol
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria (5 listed)
- History of or current liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
- History of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (latest edition DSM-5) criteria within 6 months before 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-54175446 (capsule)Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally. | Drug | Group 1: Treatment Sequence AB, Group 1: Treatment Sequence BA, Group 2: Treatment Sequence CD, Group 2: Treatment Sequence DC |
| JNJ-54175446 (suspension)Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally. | Drug | Group 1: Treatment Sequence AB, Group 1: Treatment Sequence BA, Group 2: Treatment Sequence CD, Group 2: Treatment Sequence DC |
Primary outcome
Maximum Plasma Concentration (Cmax) of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
The Cmax is the maximum observed plasma concentration.
Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
The Tmax is defined as actual sampling time to reach maximum plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
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(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Elimination Rate Constant (Lambda[z]) of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Elimination Half-Life (t1/2) of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
The elimination half-life (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 is calculated as 0.693/lambda(z).
Relative Bioavailability of JNJ-54175446
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose
Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of capsule to suspension formulation).
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline up to 9 Weeks
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 16 Feb 2017.
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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-54175446 (capsule) and JNJ-54175446 (suspension) 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 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 16 Feb 2017. 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 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 Plasma Concentration (Cmax) of JNJ-54175446 (time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose). The study lists 7 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 16 Feb 2017.