HealthyPhase 1NCT03007693
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants
A Phase 1 study testing JNJ-61393215 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-61393215
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to Oct 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants between 18 and 55 years of age, inclusive
- Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height square)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [incl. QTcF less than or equal to [<=] 450 milliseconds (msec) for males] performed at screening and admission to the clinical unit. Minor abnormalities in electrocardiogram (ECG), which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, 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 by the investigator
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of contraception e.g., either condom with spermicidal foam/gel/film/cream/suppository during the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug. All men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partner should also use a highly effective method of contraception for at least the same duration. Examples of highly effective contraceptives include implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.), combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable.
- Participants must be willing to adhere to the prohibitions and restrictions specified in this protocol
Who cannot join
- Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable
- Current or past history of any psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or DSM-V, with the exclusion of an anxiety disorder (i.e., panic disorder with or without agoraphobia, social anxiety disorder, and generalized anxiety disorder)
- Participant has any liver function test (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyltransferase [gGT], alkaline phosphatase [ALP and bilirubin] at screening exceeding the upper limit of normal
- Participant has estimated glomerular filtration rate (eGFR) <60 milliliter per minute (mL/min)/1.73m^2 at screening (provided by the local laboratory)
- Participant has a heart rate < 50 beats per minute (bpm) or > 100 bpm or systolic blood pressure greater than or equal to (>=) 150 millimeter of mercury (mmHg) at screening or at admission to the clinical unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Subjects
The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations.
- Conditions
- Healthy
- Being tested
- JNJ-61393215, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-61393215Drug
Participants will receive JNJ-61393215 for 7 days.
PlaceboDrug
Participants will receive JNJ- 61393215 matching placebo for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-61393215 (Multiple Ascending Dose Phase) | Experimental | Participants will receive JNJ- 61393215 once daily for 7 days. 4 sequential cohorts will be enrolled to evaluate escalating doses which will be defined, based on safety, tolerability and pharmacokinetic (PK) data from the preceding cohorts. Dose adjustment/selection (increase/decrease) for the next cohort will be based on the JNJ- 61393215 PK profile up to and including the last day of dosing (24 hours postdose) and the safety and tolerability profile of the current cohort. Receives: Drug: JNJ-61393215 |
| Placebo (Multiple Ascending Dose Phase) | Placebo comparator | Participants will receive JNJ- 61393215 matching placebo for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Measured: up to 4 weeks
Time To Reach The Maximum Plasma Concentration (Tmax)
Tmax is time to reach the maximum plasma concentration.
Measured: Day 1
Maximum Plasma Concentration (Cmax)
Cmax is maximum plasma concentration.
Measured: Day 1
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
AUC[0-24] is area under the plasma concentration- time curve from time [0 to 24].
Measured: Day 1
The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Measured: Days 2 to 6
The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Measured: Day 7
Minimum Observed Plasma Concentration During Dosing Interval (tau) (Cmin)
Cmin is minimum observed plasma concentration during dosing interval (tau).
Measured: Day 7
Time To Reach The Maximum Plasma Concentration (Tmax)
Tmax is time to reach the maximum plasma concentration.
Measured: Day 7
Maximum Plasma Concentration (Cmax)
Cmax is maximum plasma concentration.
Measured: Day 7
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
AUC[0-24] is Area under the plasma concentration- time curve from time [0 to 24].
Measured: Day 7
Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
Cavg is average plasma concentration at steady state over the dosing interval.
Measured: Day 7
Fluctuation Index (FI)
Fluctuation Index is defined as percentage of fluctuation, calculated as: 100*([Cmax-Cmin]/Cavg).
Measured: Day 7
Total Apparent Oral Clearance, Calculated as Dose/AUCtau at Steady-State (CL/F)
CL/F is total apparent oral clearance, calculated as dose/AUCtau at steady-state.
Measured: Day 7
Apparent Terminal Elimination Rate Constant, Determined By Linear Regression of the Terminal Points of the Ln-Linear Plasma Concentration-Time Curve (Lambda[Z])
Lambda[Z] is apparent terminal elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Measured: Day 7
Apparent Elimination Half-Life Associated With The Terminal Slope of The Semilogarithmic Drug Concentration-Time Curve, After Multiple-Dose Administration Only (t1/2term)
T1/2term is apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, after multiple-dose administration only.
Measured: Day 7
Ratio of Maximum Plasma Concentration (Cmax) Test (Day 7 [steady-state]/ref (Day 1) (Ratio Cmax,test/ref)
Ratio Cmax,test/ref is ratio of maximum plasma concentration (Cmax) test (day 7 [steady-state]/ref (day 1).
Measured: Day 7
Ratio of Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) Test (Day 7 [steady-state]/ref (Day 1) (Ratio AUC24h,test/ref)
Ratio AUC24h,test/ref is ratio of area under the plasma concentration- time curve from time [0 to 24] (AUC[0-24]) test (day 7 [steady-state]/ref (day 1).
Measured: Day 7
Secondary outcomes (1)
Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale
Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end. The Bond-Lader of a 10 cm line. Participants will rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item is scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria are then calculated from the combined scores of selected items. The score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2017
- Study completionOct 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.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 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
- NCT03007693
- Sponsor's protocol ID
- CR108250
- Other IDs
- 2016-003894-16, 61393215EDI1002, 2016
- Status last verified
- Apr 2025
- First submitted
- 30 Dec 2016
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03007693
- Acronym / sponsor ID
- CR108250
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Jan 2017 (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 investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-61393215 (Multiple Ascending Dose Phase) | Experimental | Drug: JNJ-61393215Participants will receive JNJ- 61393215 once daily for 7 days. 4 sequential cohorts will be enrolled to evaluate escalating doses which will be defined, based on safety, tolerability and pharmacokinetic (PK) data from the preceding cohorts. Dose adjustment/selection (increase/decrease) for the next cohort will be based on the JNJ- 61393215 PK profile up to and including the last day of dosing (24 hours postdose) and the safety and tolerability profile of the current cohort. |
| Placebo (Multiple Ascending Dose Phase) | Placebo comparator | Drug: PlaceboParticipants will receive JNJ- 61393215 matching placebo for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male participants between 18 and 55 years of age, inclusive
- Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height square)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [incl. QTcF less than or equal to [<=] 450 milliseconds (msec) for males] performed at screening and admission to the clinical unit. Minor abnormalities in electrocardiogram (ECG), which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, 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 by the investigator
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of contraception e.g., either condom with spermicidal foam/gel/film/cream/suppository during the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug. All men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partner should also use a highly effective method of contraception for at least the same duration. Examples of highly effective contraceptives include implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.), combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable.
Key exclusion criteria (5 listed)
- Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable
- Current or past history of any psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or DSM-V, with the exclusion of an anxiety disorder (i.e., panic disorder with or without agoraphobia, social anxiety disorder, and generalized anxiety disorder)
- Participant has any liver function test (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyltransferase [gGT], alkaline phosphatase [ALP and bilirubin] at screening exceeding the upper limit of normal
- Participant has estimated glomerular filtration rate (eGFR) <60 milliliter per minute (mL/min)/1.73m^2 at screening (provided by the local laboratory)
- Participant has a heart rate < 50 beats per minute (bpm) or > 100 bpm or systolic blood pressure greater than or equal to (>=) 150 millimeter of mercury (mmHg) at screening or at admission to the clinical unit
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-61393215Participants will receive JNJ-61393215 for 7 days. | Drug | JNJ-61393215 (Multiple Ascending Dose Phase) |
| PlaceboParticipants will receive JNJ- 61393215 matching placebo for 7 days. | Drug | Placebo (Multiple Ascending Dose Phase) |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 4 weeks
Time To Reach The Maximum Plasma Concentration (Tmax)
Time frame: Day 1
Tmax is time to reach the maximum plasma concentration.
Maximum Plasma Concentration (Cmax)
Time frame: Day 1
Cmax is maximum plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
Time frame: Day 1
AUC[0-24] is area under the plasma concentration- time curve from time [0 to 24].
The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Time frame: Days 2 to 6
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Time frame: Day 7
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Minimum Observed Plasma Concentration During Dosing Interval (tau) (Cmin)
Time frame: Day 7
Cmin is minimum observed plasma concentration during dosing interval (tau).
Time To Reach The Maximum Plasma Concentration (Tmax)
Time frame: Day 7
Tmax is time to reach the maximum plasma concentration.
Maximum Plasma Concentration (Cmax)
Time frame: Day 7
Cmax is maximum plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
Time frame: Day 7
AUC[0-24] is Area under the plasma concentration- time curve from time [0 to 24].
Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
Time frame: Day 7
Cavg is average plasma concentration at steady state over the dosing interval.
Fluctuation Index (FI)
Time frame: Day 7
Fluctuation Index is defined as percentage of fluctuation, calculated as: 100*([Cmax-Cmin]/Cavg).
Total Apparent Oral Clearance, Calculated as Dose/AUCtau at Steady-State (CL/F)
Time frame: Day 7
CL/F is total apparent oral clearance, calculated as dose/AUCtau at steady-state.
Apparent Terminal Elimination Rate Constant, Determined By Linear Regression of the Terminal Points of the Ln-Linear Plasma Concentration-Time Curve (Lambda[Z])
Time frame: Day 7
Lambda[Z] is apparent terminal elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Apparent Elimination Half-Life Associated With The Terminal Slope of The Semilogarithmic Drug Concentration-Time Curve, After Multiple-Dose Administration Only (t1/2term)
Time frame: Day 7
T1/2term is apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, after multiple-dose administration only.
Ratio of Maximum Plasma Concentration (Cmax) Test (Day 7 [steady-state]/ref (Day 1) (Ratio Cmax,test/ref)
Time frame: Day 7
Ratio Cmax,test/ref is ratio of maximum plasma concentration (Cmax) test (day 7 [steady-state]/ref (day 1).
Ratio of Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) Test (Day 7 [steady-state]/ref (Day 1) (Ratio AUC24h,test/ref)
Time frame: Day 7
Ratio AUC24h,test/ref is ratio of area under the plasma concentration- time curve from time [0 to 24] (AUC[0-24]) test (day 7 [steady-state]/ref (day 1).
1 secondary outcome
Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale
Time frame: Day 1 and Day 7
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 27 Apr 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-61393215 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability (time frame: up to 4 weeks). The study lists 17 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 27 Apr 2025.