HealthyPhase 1NCT03058419

A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects

A Phase 1 study testing JNJ-54175446 150 mg, JNJ-54175446 600 mg and Midazolam 2 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to determine the potential inhibitory/inducing effects of JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a cocktail, containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A4/A5, CYP2C9, CYP1A2, CYP2D6, CYP2B6, and CYP2C19) in… 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-54175446 150 mg, JNJ-54175446 600 mg and Midazolam 2 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteBelgium
Study dates: 14 Mar 2017to 15 May 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

Subject must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive (BMI = weight/height^2)
Subject must be healthy on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiograms (ECGs), including QTc according to Fridericia's formula (QTcF) less than or equal to (</=) 450 milliseconds (ms) for males and </= 470 ms for females, performed at screening and first admission to the study site
Subject must be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the hematology, serology, serum chemistry (excluding liver function tests, which must be in normal range of 1.25 * upper limit of normal laboratory range), and coagulation panel, 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
During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a male subject: Who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a barrier method of contraception (eg, 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). In addition, their female partner should also use a highly effective method of birth control (example, hormonal contraception) for at least the same duration. Who is sexually active with a woman who is pregnant must use a condom and Must agree not to donate sperm
A female subject must be of non-childbearing potential at screening

Who cannot join

Subject has a history of or current liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute (mL/min), significant skin disease such as, but not limited to, dermatitis, eczema, Stevens-Johnson Syndrome, drug rash, psoriasis or urticaria, 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 subject
Subject 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
Subject has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Subject has a 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)
Subject has a history of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria within 6 months before screening

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Clinical Pharmacology Unit
Merksem, 2170

Other trials in Belgium

About this study

Official title: An Open-label Drug Interaction Study in Healthy Subjects to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail

Conditions: Healthy
Being tested: JNJ-54175446 150 mg, JNJ-54175446 600 mg, Midazolam 2 mg, Warfarin 10 mg, Caffeine 50 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-54175446 150 mgDrug
Subjects will receive JNJ-54175446 150 mg capsules orally (1*100 mg + 1*50 mg) under fasted conditions on Day 7, 9, 10 and 11.
JNJ-54175446 600 mgDrug
Subjects will receive JNJ-54175446 600 mg (6*100 mg capsules) orally on Day 8.
Midazolam 2 mgDrug
Subjects will receive midazolam 2 mg oral emulsion [2 (milligram per milliliter (mg/mL)] as a drug cocktail on Day 1, 7 and 11.
Warfarin 10 mgDrug
Subjects will receive warfarin 10 mg tablets (2*5 mg) orally as a drug cocktail on Day 1, 7 and 11.
Caffeine 50 mgDrug
Subjects will receive caffeine 50 mg tablet (1*50 mg) orally as a drug cocktail on Day 1, 7 and 11.
Dextromethorphan 30 mgDrug
Subjects will receive dextromethorphan 30 mg capsule (1*30 mg) orally as a drug cocktail on Day 1, 7 and 11.
Bupropion 150 mgDrug
Subjects will receive Bupropion 150 mg tablet (1*150 mg) orally as a drug cocktail on Day 1, 7 and 11.
Omeprazole 20 mgDrug
Subjects will receive omeprazole 20 mg capsule (1*20 mg) orally as a drug cocktail on Day 1, 7 and 11.

Study groups in NCT03058419
Study group	Role	What they receive
Drug Cocktail + JNJ-54175446	Experimental	All subjects will receive a single dose of drug cocktail (consisting of midazolam [2 milligram (mg)], warfarin [10 mg], caffeine [50 mg], dextromethorphan [30 mg], bupropion [150 mg] and omeprazole [20 mg]) on Day 1, 7 and 11; JNJ-54175446 150 mg on Day 7, 9, 10 and 11 and JNJ-54175446 600 mg on Day 8. Receives: Drug: JNJ-54175446 150 mg; Drug: JNJ-54175446 600 mg; Drug: Midazolam 2 mg; Drug: Warfarin 10 mg; Drug: Caffeine 50 mg; Drug: Dextromethorphan 30 mg; Drug: Bupropion 150 mg; Drug: Omeprazole 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Up to Day 17
Plasma Trough Concentration (Ctrough)
Ctrough is defined as observed plasma concentration of drug just prior to the beginning or at the end of a dosing interval.
Measured: Up to Day 17
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Measured: Up to Day 17
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last])
The AUClast is the area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit) concentration.
Measured: Up to Day 17
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(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: Up to Day 17
Elimination Rate Constant (Lambda [z])
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: 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: Up to Day 17
Apparent Total Clearance (CL/F)
Apparent total clearance is calculated as dose/AUC(0-infinity).
Measured: Up to Day 17
Apparent Volume of Distribution (Vd/F)
Apparent volume of distribution, calculated as dose/(lambda[z]*AUC[0-infinity]).
Measured: Up to Day 17
Parent to Metabolite Ratio (Cmax)
Parent to metabolite ratio Cmax is defined as the ratio of individual Cmax values between parent and metabolite.
Measured: Up to Day 17
Parent to Metabolite Ratio (AUC [Last])
Parent to metabolite ratio (AUC [Last]) is defined as ratio of individual (AUC [Last]) values between parent and metabolite.
Measured: Up to Day 17
Parent to Metabolite Ratio (AUC [infinity])
Parent to Metabolite Ratio (AUC [infinity]) is defined as the ratio of individual (AUC [infinity]) values between parent and metabolite.
Measured: Up to Day 17

Secondary outcomes (1)

Number of Subjects With Adverse Events (AEs) as a Measure of Safety and Tolerability
Safety and Tolerability
Measured: Up to follow up (14 to 21 days after last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 201715 May 2017

First posted20 Feb 2017
Study start14 Mar 2017
Primary completion15 May 2017
Study completion15 May 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03058419
Sponsor's protocol ID: CR108283
Other IDs: 2016-004167-39, 54175446EDI1006, 2016
Status last verified: Jun 2017
First submitted: 16 Feb 2017
Last updated: 8 Jun 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Drug Interaction Study in Healthy Subjects to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail
ClinicalTrials.gov ID: NCT03058419
Acronym / sponsor ID: CR108283
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 14 Mar 2017 (actual)
Primary completion: 15 May 2017 (actual)
Study completion: 15 May 2017 (actual)
First posted: 20 Feb 2017 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Drug Cocktail + JNJ-54175446	Experimental	Drug: JNJ-54175446 150 mg, Drug: JNJ-54175446 600 mg, Drug: Midazolam 2 mg, Drug: Warfarin 10 mg, Drug: Caffeine 50 mg, Drug: Dextromethorphan 30 mg, Drug: Bupropion 150 mg, Drug: Omeprazole 20 mgAll subjects will receive a single dose of drug cocktail (consisting of midazolam [2 milligram (mg)], warfarin [10 mg], caffeine [50 mg], dextromethorphan [30 mg], bupropion [150 mg] and omeprazole [20 mg]) on Day 1, 7 and 11; JNJ-54175446 150 mg on Day 7, 9, 10 and 11 and JNJ-54175446 600 mg on Day 8.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subject must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive (BMI = weight/height^2)
Subject must be healthy on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiograms (ECGs), including QTc according to Fridericia's formula (QTcF) less than or equal to (</=) 450 milliseconds (ms) for males and </= 470 ms for females, performed at screening and first admission to the study site
Subject must be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the hematology, serology, serum chemistry (excluding liver function tests, which must be in normal range of 1.25 * upper limit of normal laboratory range), and coagulation panel, 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
During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a male subject: Who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a barrier method of contraception (eg, 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). In addition, their female partner should also use a highly effective method of birth control (example, hormonal contraception) for at least the same duration. Who is sexually active with a woman who is pregnant must use a condom and Must agree not to donate sperm
A female subject must be of non-childbearing potential at screening

Key exclusion criteria (5 listed)

Subject has a history of or current liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute (mL/min), significant skin disease such as, but not limited to, dermatitis, eczema, Stevens-Johnson Syndrome, drug rash, psoriasis or urticaria, 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 subject
Subject 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
Subject has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Subject has a 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)
Subject has a history of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) 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 150 mgSubjects will receive JNJ-54175446 150 mg capsules orally (1100 mg + 150 mg) under fasted conditions on Day 7, 9, 10 and 11.	Drug	Drug Cocktail + JNJ-54175446
JNJ-54175446 600 mgSubjects will receive JNJ-54175446 600 mg (6*100 mg capsules) orally on Day 8.	Drug	Drug Cocktail + JNJ-54175446
Midazolam 2 mgSubjects will receive midazolam 2 mg oral emulsion [2 (milligram per milliliter (mg/mL)] as a drug cocktail on Day 1, 7 and 11.	Drug	Drug Cocktail + JNJ-54175446
Warfarin 10 mgSubjects will receive warfarin 10 mg tablets (2*5 mg) orally as a drug cocktail on Day 1, 7 and 11.	Drug	Drug Cocktail + JNJ-54175446
Caffeine 50 mgSubjects will receive caffeine 50 mg tablet (1*50 mg) orally as a drug cocktail on Day 1, 7 and 11.	Drug	Drug Cocktail + JNJ-54175446
Dextromethorphan 30 mgSubjects will receive dextromethorphan 30 mg capsule (1*30 mg) orally as a drug cocktail on Day 1, 7 and 11.	Drug	Drug Cocktail + JNJ-54175446
Bupropion 150 mgSubjects will receive Bupropion 150 mg tablet (1*150 mg) orally as a drug cocktail on Day 1, 7 and 11.	Drug	Drug Cocktail + JNJ-54175446
Omeprazole 20 mgSubjects will receive omeprazole 20 mg capsule (1*20 mg) orally as a drug cocktail on Day 1, 7 and 11.	Drug	Drug Cocktail + JNJ-54175446

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 17
The Cmax is the maximum observed plasma concentration.
Plasma Trough Concentration (Ctrough)
Time frame: Up to Day 17
Ctrough is defined as observed plasma concentration of drug just prior to the beginning or at the end of a dosing interval.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 17
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last])
Time frame: Up to Day 17
The AUClast is the area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit) concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Up to Day 17
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(last) and C(last)/lambda(z); wherein AUC(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])
Time frame: Up to Day 17
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)
Time frame: 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).
Apparent Total Clearance (CL/F)
Time frame: Up to Day 17
Apparent total clearance is calculated as dose/AUC(0-infinity).
Apparent Volume of Distribution (Vd/F)
Time frame: Up to Day 17
Apparent volume of distribution, calculated as dose/(lambda[z]*AUC[0-infinity]).
Parent to Metabolite Ratio (Cmax)
Time frame: Up to Day 17
Parent to metabolite ratio Cmax is defined as the ratio of individual Cmax values between parent and metabolite.
Parent to Metabolite Ratio (AUC [Last])
Time frame: Up to Day 17
Parent to metabolite ratio (AUC [Last]) is defined as ratio of individual (AUC [Last]) values between parent and metabolite.
Parent to Metabolite Ratio (AUC [infinity])
Time frame: Up to Day 17
Parent to Metabolite Ratio (AUC [infinity]) is defined as the ratio of individual (AUC [infinity]) values between parent and metabolite.

1 secondary outcome

Number of Subjects With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to follow up (14 to 21 days after last dose)

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 8 Jun 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 150 mg, JNJ-54175446 600 mg and Midazolam 2 mg in people with Healthy, run by Janssen Research & Development, LLC 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 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 8 Jun 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 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 Plasma Concentration (Cmax) (time frame: Up to Day 17). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058419.

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 8 Jun 2017.