HealthyPhase 1NCT02515955
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Participants
A Phase 1 study testing JNJ-54175446, Minocycline and D Amphetamine in people with Healthy, run by Janssen-Cilag International NV at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of JNJ-54175446 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-54175446, Minocycline and D Amphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Mar 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must have a body mass index (BMI) between 18 and 32 kilogram/meter^2 (kg/m^2), inclusive (BMI = weight/height^2)
- Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) [including QTcF less than or equal to 450 millisecond (ms) (triplicate ECG)] performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the 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
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel [including liver enzymes], hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the subject'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 birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and 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 an appropriate method of birth control for at least the same duration
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 that the Investigator considers should exclude the subject
- Participant has a clinically significant (history of) psychiatric illnesses or (history of) psychotic symptoms
- Participant has a family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree)
- Participant 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
- Participant 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 Randomized, Placebo- and Comparator-controlled, Double-blind, Multiple (Ascending) Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of JNJ-54175446 after multiple consecutive dose administrations
Read the detailed description
This will be a randomized, placebo-and comparator-controlled, double-blind, multiple dose study with JNJ-54175446 in healthy male participants. The study will consist of a Screening examination (28 to 6 days prior to dose administration), a baseline 20 mg amphetamine (AMPH) challenge at least 5 days before first dose administration, a double-blind treatment period (18 days; 11 days of dosing with JNJ-54175446, minocycline or placebo; amphetamine (AMPH)/AMPH placebo challenge sequence on Day 7 and Day 10 for each participant), and a follow-up examination between 14 and 21 days after last dose administration. The maximal study duration for each participant will not exceed 9 weeks. Safety, pharmacokinetics (PK) and pharmacodynamics of JNJ-54175446 will be primarily assessed. Safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- JNJ-54175446, Minocycline, JNJ 54175446 Matching Placebo, D Amphetamine, D Amphetamine Matching Placebo
- Keywords
- Healthy, JNJ-54175446
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54175446Drug
Participants will receive JNJ-54175446, at increasing dose levels using 2 oral formulations i.e. 0.5 mg/ml and 20 mg/ml as suspension for oral dose once daily.
MinocyclineDrug
Participants will receive minocycline 100 mg as capsule twice daily.
JNJ 54175446 Matching PlaceboDrug
Participants will receive placebo matching with JNJ 54175446 once daily orally.
D AmphetamineDrug
Participants will receive 20 mg d-amphetamine (AMPH) 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
D Amphetamine Matching PlaceboDrug
Participants will receive d-amphetamine (AMPH) matching placebo, 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: Minocycline; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 2 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: Minocycline; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 3 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: Minocycline; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 4 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: Minocycline; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 5 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: Minocycline; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 6 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: Minocycline; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 7 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
| Cohort 8 | Experimental | Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. Receives: Drug: JNJ-54175446; Drug: JNJ 54175446 Matching Placebo; Drug: D Amphetamine; Drug: D Amphetamine Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Baseline up to 14 or 21 days after study drug administration
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed concentration.
Measured: Baseline up to Day 17
Minimum Observed Plasma Concentration (Cmin)
The Cmin is the minimum observed plasma concentration.
Measured: Baseline up to Day 17
Trough Plasma Concentration (Ctrough)
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
Measured: Baseline up to Day 17
Average Plasma Concentration at Steady State (Cavg,ss)
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).
Measured: Baseline up to Day 17
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Baseline up to Day 17
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
Measured: Baseline up to Day 17
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
Measured: Baseline up to Day 17
Elimination Half-Life (t1/2)
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: Baseline up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 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 trials, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515955
- Sponsor's protocol ID
- CR107762
- Other IDs
- 54175446EDI1002, 2015-001300-55, 2015
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo- and Comparator-controlled, Double-blind, Multiple (Ascending) Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02515955
- Acronym / sponsor ID
- CR107762
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-54175446
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Aug 2015 (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, tolerability and pharmacodynamics of JNJ-54175446 after multiple consecutive dose administrations
Detailed description
This will be a randomized, placebo-and comparator-controlled, double-blind, multiple dose study with JNJ-54175446 in healthy male participants. The study will consist of a Screening examination (28 to 6 days prior to dose administration), a baseline 20 mg amphetamine (AMPH) challenge at least 5 days before first dose administration, a double-blind treatment period (18 days; 11 days of dosing with JNJ-54175446, minocycline or placebo; amphetamine (AMPH)/AMPH placebo challenge sequence on Day 7 and Day 10 for each participant), and a follow-up examination between 14 and 21 days after last dose administration. The maximal study duration for each participant will not exceed 9 weeks. Safety, pharmacokinetics (PK) and pharmacodynamics of JNJ-54175446 will be primarily assessed. Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: JNJ-54175446, Drug: Minocycline, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 2 | Experimental | Drug: JNJ-54175446, Drug: Minocycline, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 3 | Experimental | Drug: JNJ-54175446, Drug: Minocycline, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 4 | Experimental | Drug: JNJ-54175446, Drug: Minocycline, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 5 | Experimental | Drug: JNJ-54175446, Drug: Minocycline, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 6 | Experimental | Drug: JNJ-54175446, Drug: Minocycline, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 7 | Experimental | Drug: JNJ-54175446, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
| Cohort 8 | Experimental | Drug: JNJ-54175446, Drug: JNJ 54175446 Matching Placebo, Drug: D Amphetamine, Drug: D Amphetamine Matching PlaceboParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must have a body mass index (BMI) between 18 and 32 kilogram/meter^2 (kg/m^2), inclusive (BMI = weight/height^2)
- Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) [including QTcF less than or equal to 450 millisecond (ms) (triplicate ECG)] performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the 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
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel [including liver enzymes], hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the subject'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 birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and 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 an appropriate method of birth control for at least the same duration
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 that the Investigator considers should exclude the subject
- Participant has a clinically significant (history of) psychiatric illnesses or (history of) psychotic symptoms
- Participant has a family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree)
- Participant 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
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-54175446Participants will receive JNJ-54175446, at increasing dose levels using 2 oral formulations i.e. 0.5 mg/ml and 20 mg/ml as suspension for oral dose once daily. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| MinocyclineParticipants will receive minocycline 100 mg as capsule twice daily. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| JNJ 54175446 Matching PlaceboParticipants will receive placebo matching with JNJ 54175446 once daily orally. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| D AmphetamineParticipants will receive 20 mg d-amphetamine (AMPH) 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| D Amphetamine Matching PlaceboParticipants will receive d-amphetamine (AMPH) matching placebo, 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Number of Participants with Adverse Events
Time frame: Baseline up to 14 or 21 days after study drug administration
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline up to Day 17
The Cmax is the maximum observed concentration.
Minimum Observed Plasma Concentration (Cmin)
Time frame: Baseline up to Day 17
The Cmin is the minimum observed plasma concentration.
Trough Plasma Concentration (Ctrough)
Time frame: Baseline up to Day 17
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
Average Plasma Concentration at Steady State (Cavg,ss)
Time frame: Baseline up to Day 17
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Baseline up to Day 17
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Baseline up to Day 17
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Time frame: Baseline up to Day 17
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
Elimination Half-Life (t1/2)
Time frame: Baseline up to Day 17
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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 trials 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-54175446, Minocycline and D Amphetamine in people with Healthy, run by Janssen-Cilag International NV 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 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 Adverse Events (time frame: Baseline up to 14 or 21 days after study drug administration). The study lists 9 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.