HealthyPhase 1NCT02860806
Safety, Tolerability, Pharmacokinetic and Absolute Bioavailability Study of JNJ-63623872 Administered as an Intravenous Infusion and a 600-Milligram (mg) Oral Dose in Healthy Adults
A Phase 1 study testing JNJ-63623872 in people with Healthy, run by Janssen-Cilag International NV at 1 site in Belgium.
Trial summary
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-63623872
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Aug 2016to 10 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A female participant (except if postmenopausal) must have a negative serum beta- human chorionic gonadotropin (beta-hCG) pregnancy test at screening and on Day -1 of each treatment period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after discontinuation of study drug
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception in the female partner, a man regardless of having been vasectomized: 1) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository), 2) must agree not to donate sperm and 3) who is sexually active with a pregnant women must use a condom
- Must have a Body Mass Index (BMI); weight kilogram [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (extremes included) at Screening
- Must have a blood pressure (supine after at least 5 minutes rest and standing after at least 1 minute standing) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
Who cannot join
- Has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- With a past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Has known allergies, hypersensitivity, or intolerance to JNJ-63623872 or its excipients
- With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
- Has a 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
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Absolute Bioavailability of JNJ-63623872 Administered as an Intravenous Infusion and a 600-mg Oral Dose in Healthy Adult Subjects
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of one selected dose administered as a continuous IV infusion at various durations and to characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous infusion.
- Conditions
- Healthy
- Being tested
- JNJ-63623872, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-63623872Drug
3 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered.
PlaceboDrug
Intravenous infusion of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Period 1 (JNJ-63623872 100 mg or Placebo) | Experimental | Participants will receive a single intravenous (IV) infusion of JNJ-63623872 100 milligram (mg) [3 milligram per milliliters (mg/mL) solution] (Treatment A) or matching placebo (Treatment D) over 120 minutes. Receives: Drug: JNJ-63623872; Drug: Placebo |
| Part 1: Period 2 (JNJ-63623872 200 mg or Placebo) | Experimental | Participants will receive a single IV infusion of JNJ-63623872 200 mg (3 mg/mL solution) (Treatment B) or matching placebo (Treatment D) over 120 minutes. Receives: Drug: JNJ-63623872; Drug: Placebo |
| Part 1: Period 3 (JNJ-63623872 300 mg or Placebo) | Experimental | Participants will receive a single IV infusion of JNJ-63623872 300 mg (3 mg/mL solution) (Treatment C) or matching placebo (Treatment D) over 120 minutes. Receives: Drug: JNJ-63623872; Drug: Placebo |
| Part 2: Group 1 (EFG) | Experimental | Participants will receive a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over x minutes (Treatment E) followed by a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over y minutes (Treatment F), then a single oral 600-mg dose (2* 300 mg tablets) of JNJ-63623872 under fasted conditions (Treatment G). Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. Receives: Drug: JNJ-63623872 |
| Part 2: Group 2 (FGE) | Experimental | Participants will receive Treatment F, then Treatment G followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. Receives: Drug: JNJ-63623872 |
| Part 2: Group 3 (GEF) | Experimental | Participants will receive Treatment G, then Treatment E followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. Receives: Drug: JNJ-63623872 |
| Part 2: Group 4 (GFE) | Experimental | Participants will receive Treatment G, then Treatment F, followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. Receives: Drug: JNJ-63623872 |
| Part 2: Group 5 (FEG) | Experimental | Participants will receive Treatment F, then Treatment E followed by Treatment G. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. Receives: Drug: JNJ-63623872 |
| Part 2: Group 6 (EGF) | Experimental | Participants will receive Treatment E, then Treatment G followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. Receives: Drug: JNJ-63623872 |
| Part 3: JNJ-63623872 300 mg | Experimental | Participants will receive multiple IV infusions of JNJ-63623872 300 mg (3 mg/mL) solution every 12 hours on Days 1 to 10, with only a morning dose on Day 10. Duration of infusion and dose will be selected after Part 2 of this study is completed. Receives: Drug: JNJ-63623872 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Analyte Concentration (Cmax)
The Cmax is the maximum observed analyte concentration.
Measured: Up to 10 days
Fluctuation Index (FI)
FI is defined as the percentage fluctuation between the Ctrough, morning analyte concentration and the maximum analyte concentration.
Measured: Up to 10 days
Average Analyte Concentration (Cavg)
The Cavg is an average analyte concentration at steady-state over the dosing interval.
Measured: Up to 10 days
Time to Reach the Maximum Observed Analyte Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Up to 10 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12])
The (AUC [0-12]) is the area under the plasma concentration-time curve from time 0 to 12 hour post dose, calculated by linear-linear trapezoidal summation.
Measured: Up to 10 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last])
The (AUC [0-last]) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measured: Up to 10 days
Area Under the 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 0 to infinity, calculated as the sum of AUC(last) and C(last)/lambda(z), where Clast is the last observed measurable (non-BQL) concentration; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.
Measured: Up to 10 days
Elimination Rate Constant (Lambda[z])
Lambda(z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.
Measured: Up to 10 days
Apparent Terminal Elimination Half-life (t1/2term)
Apparent terminal elimination half-life is defined as 0.693/Lambda[z].
Measured: Up to 10 days
Systemic Clearance (CL)
CL is the total systemic clearance, following intravenous administration.
Measured: Up to 10 days
Apparent Clearance (CL/F)
CL/F is the total apparent clearance, following extravascular administration.
Measured: Up to 10 days
Volume of Distribution (Vd)
The Vd is defined as volume of distribution, following single dose intravenous administration.
Measured: Up to 10 days
Apparent Volume of Distribution (Vd/F)
Vd/F is defined as apparent volume of distribution, following single dose extravascular administration.
Measured: Up to 10 days
Volume of Distribution at Steady-State (Vss)
Vss is defined as apparent volume of distribution at steady-state following intravenous administration.
Measured: Up to 10 days
Observed Accumulation Index (RA abs)
Observed Accumulation Index is calculated by AUC12h, steady state/(AUC12h, single dose).
Measured: Up to 10 days
Morning Trough Analyte Concentration (Ctrough, morning)
Ctrough, morning is defined as observed analyte concentration just prior to the beginning of a dosing interval.
Measured: Up to 10 days
Evening Trough Analyte Concentration (Ctrough, evening)
Ctrough, evening is defined as observed analyte concentration at the end of a dosing interval.
Measured: Up to 10 days
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Measured: Up to End of Study (Day 14)
Secondary outcomes (1)
Absolute Bioavailability (F[abs])
The F(abs) is calculated as AUC (0-infinity), oral/ AUC (0-infinity), intravenous (iv)*Dose, iv/Dose, oral*100 %, where AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start8 Aug 2016
- Primary completion6 Jun 2017
- Study completion10 Jun 2017
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.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860806
- Sponsor's protocol ID
- CR108196
- Other IDs
- 63623872FLZ1002, 2016-000921-37, 2016
- Status last verified
- Jan 2018
- First submitted
- 5 Aug 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Absolute Bioavailability of JNJ-63623872 Administered as an Intravenous Infusion and a 600-mg Oral Dose in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02860806
- Acronym / sponsor ID
- CR108196
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 9 Aug 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 this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of one selected dose administered as a continuous IV infusion at various durations and to characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1: Period 1 (JNJ-63623872 100 mg or Placebo) | Experimental | Drug: JNJ-63623872, Drug: PlaceboParticipants will receive a single intravenous (IV) infusion of JNJ-63623872 100 milligram (mg) [3 milligram per milliliters (mg/mL) solution] (Treatment A) or matching placebo (Treatment D) over 120 minutes. |
| Part 1: Period 2 (JNJ-63623872 200 mg or Placebo) | Experimental | Drug: JNJ-63623872, Drug: PlaceboParticipants will receive a single IV infusion of JNJ-63623872 200 mg (3 mg/mL solution) (Treatment B) or matching placebo (Treatment D) over 120 minutes. |
| Part 1: Period 3 (JNJ-63623872 300 mg or Placebo) | Experimental | Drug: JNJ-63623872, Drug: PlaceboParticipants will receive a single IV infusion of JNJ-63623872 300 mg (3 mg/mL solution) (Treatment C) or matching placebo (Treatment D) over 120 minutes. |
| Part 2: Group 1 (EFG) | Experimental | Drug: JNJ-63623872Participants will receive a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over x minutes (Treatment E) followed by a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over y minutes (Treatment F), then a single oral 600-mg dose (2* 300 mg tablets) of JNJ-63623872 under fasted conditions (Treatment G). Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Part 2: Group 2 (FGE) | Experimental | Drug: JNJ-63623872Participants will receive Treatment F, then Treatment G followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Part 2: Group 3 (GEF) | Experimental | Drug: JNJ-63623872Participants will receive Treatment G, then Treatment E followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Part 2: Group 4 (GFE) | Experimental | Drug: JNJ-63623872Participants will receive Treatment G, then Treatment F, followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Part 2: Group 5 (FEG) | Experimental | Drug: JNJ-63623872Participants will receive Treatment F, then Treatment E followed by Treatment G. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Part 2: Group 6 (EGF) | Experimental | Drug: JNJ-63623872Participants will receive Treatment E, then Treatment G followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Part 3: JNJ-63623872 300 mg | Experimental | Drug: JNJ-63623872Participants will receive multiple IV infusions of JNJ-63623872 300 mg (3 mg/mL) solution every 12 hours on Days 1 to 10, with only a morning dose on Day 10. Duration of infusion and dose will be selected after Part 2 of this study is completed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A female participant (except if postmenopausal) must have a negative serum beta- human chorionic gonadotropin (beta-hCG) pregnancy test at screening and on Day -1 of each treatment period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after discontinuation of study drug
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception in the female partner, a man regardless of having been vasectomized: 1) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository), 2) must agree not to donate sperm and 3) who is sexually active with a pregnant women must use a condom
- Must have a Body Mass Index (BMI); weight kilogram [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (extremes included) at Screening
- Must have a blood pressure (supine after at least 5 minutes rest and standing after at least 1 minute standing) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
Key exclusion criteria (7 listed)
- Has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- With a past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Has known allergies, hypersensitivity, or intolerance to JNJ-63623872 or its excipients
- With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
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-636238723 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered. | Drug | Part 1: Period 1 (JNJ-63623872 100 mg or Placebo), Part 1: Period 2 (JNJ-63623872 200 mg or Placebo), Part 1: Period 3 (JNJ-63623872 300 mg or Placebo), Part 2: Group 1 (EFG), Part 2: Group 2 (FGE), Part 2: Group 3 (GEF), Part 2: Group 4 (GFE), Part 2: Group 5 (FEG), Part 2: Group 6 (EGF), Part 3: JNJ-63623872 300 mg |
| PlaceboIntravenous infusion of matching placebo. | Drug | Part 1: Period 1 (JNJ-63623872 100 mg or Placebo), Part 1: Period 2 (JNJ-63623872 200 mg or Placebo), Part 1: Period 3 (JNJ-63623872 300 mg or Placebo) |
Primary outcome
Maximum Observed Analyte Concentration (Cmax)
Time frame: Up to 10 days
The Cmax is the maximum observed analyte concentration.
Fluctuation Index (FI)
Time frame: Up to 10 days
FI is defined as the percentage fluctuation between the Ctrough, morning analyte concentration and the maximum analyte concentration.
Average Analyte Concentration (Cavg)
Time frame: Up to 10 days
The Cavg is an average analyte concentration at steady-state over the dosing interval.
Time to Reach the Maximum Observed Analyte Concentration (Tmax)
Time frame: Up to 10 days
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12])
Time frame: Up to 10 days
The (AUC [0-12]) is the area under the plasma concentration-time curve from time 0 to 12 hour post dose, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last])
Time frame: Up to 10 days
The (AUC [0-last]) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Up to 10 days
The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(last) and C(last)/lambda(z), where Clast is the last observed measurable (non-BQL) concentration; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.
Elimination Rate Constant (Lambda[z])
Time frame: Up to 10 days
Lambda(z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.
Apparent Terminal Elimination Half-life (t1/2term)
Time frame: Up to 10 days
Apparent terminal elimination half-life is defined as 0.693/Lambda[z].
Systemic Clearance (CL)
Time frame: Up to 10 days
CL is the total systemic clearance, following intravenous administration.
Apparent Clearance (CL/F)
Time frame: Up to 10 days
CL/F is the total apparent clearance, following extravascular administration.
Volume of Distribution (Vd)
Time frame: Up to 10 days
The Vd is defined as volume of distribution, following single dose intravenous administration.
Apparent Volume of Distribution (Vd/F)
Time frame: Up to 10 days
Vd/F is defined as apparent volume of distribution, following single dose extravascular administration.
Volume of Distribution at Steady-State (Vss)
Time frame: Up to 10 days
Vss is defined as apparent volume of distribution at steady-state following intravenous administration.
Observed Accumulation Index (RA abs)
Time frame: Up to 10 days
Observed Accumulation Index is calculated by AUC12h, steady state/(AUC12h, single dose).
Morning Trough Analyte Concentration (Ctrough, morning)
Time frame: Up to 10 days
Ctrough, morning is defined as observed analyte concentration just prior to the beginning of a dosing interval.
Evening Trough Analyte Concentration (Ctrough, evening)
Time frame: Up to 10 days
Ctrough, evening is defined as observed analyte concentration at the end of a dosing interval.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to End of Study (Day 14)
1 secondary outcome
Absolute Bioavailability (F[abs])
Time frame: Up to 10 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 30 Jan 2018.
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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-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
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-63623872 in people with Healthy, run by Janssen-Cilag International NV 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 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: finished, as of the sponsor's last update on 30 Jan 2018. 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 Analyte Concentration (Cmax) (time frame: Up to 10 days). The study lists 18 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 30 Jan 2018.