HealthyPhase 1NCT02595268

A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants

A Phase 1 study testing Pitavastatin and JNJ-63623872 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 purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Pitavastatin and JNJ-63623872
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteBelgium
Study dates: Nov 2015to Jan 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
A female participant of childbearing potential must have a negative serum beta-human chorionic gonadotropin test at Screening and a negative urine pregnancy test on Day -1
A female participant must agree not to donate eggs (ova, oocytes) throughout the study and for at least 90 days after receiving the last dose of study drug
A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of birth control, and all male participants must also agree not to donate sperm throughout the study and for 90 days after receiving the last dose of study drug
Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m^2), extremes included

Who cannot join

Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction [calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening], significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances, or a predisposition to myopathy
Participants with one or more laboratory abnormalities as specified in protocol, at Screening as defined by the World Health Organization (WHO) Toxicity Grading Scale
Participant with a past history of clinically significant heart arrhythmia (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Antwerp

Other trials in Belgium

About this study

Official title: A Phase 1, Open-label, Sequential Study to Investigate the Effect of JNJ 63623872 on Pitavastatin in Healthy Subjects

The purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.

Read the detailed description

This is a Phase 1, open-label (identity of study drug will be known to participant and study staff), sequential study in healthy volunteers to investigate the potential Pharmacokinetics (PK) effects of JNJ-872 on pitavastatin. The study consists of Screening Phase (28 days), Treatment Phase (Day 1 - Day 12), Follow up (10-14 days and 30-35 days after last study drug intake or drop). The total duration of the study will be approximately 2 months. Participants will sequentially receive the following treatment: a single oral dose of pitavastatin 1 milligram (mg) on Day 1; JNJ-63623872 600 mg twice daily on Days 4 through 12, with a single oral dose of pitavastatin 1 mg administered in the morning of Day 9. All study drug intakes will be taken orally, under fed conditions (within approximately 10 minutes after completion of a meal). Blood samples will be collected to assess pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: Pitavastatin, JNJ-63623872
Keywords: Healthy, Pitavastatin, JNJ-63623872

What participants receive

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

PitavastatinDrug
Participants will receive single oral dose of pitavastatin 1 milligram (mg) on Day 1 and Day 9.
JNJ-63623872Drug
Participants will receive JNJ-63623872 600 mg twice daily on Days 4 through 12.

Study groups in NCT02595268
Study group	Role	What they receive
Pitavastatin Then JNJ-63623872	Experimental	Participants will sequentially receive single oral dose of pitavastatin 1 milligram (mg) on Day 1, followed by JNJ-63623872 600 mg twice daily on Days 4 through 12 with a single oral dose of pitavastatin 1 mg administered in the morning of Day 9. All study drug intakes will be taken orally, under fed conditions (within approximately 10 minutes after completion of a meal). Receives: Drug: Pitavastatin; Drug: JNJ-63623872

What is being measured

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

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Measured: 72 hour (hr) post-dose on Day 7, 8; predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872
Cmin is the minimum observed analyte concentration.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872
Cmax is the maximum observed analyte concentration.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-63623872
Tmax is the actual sampling time to reach the maximum observed analyte Concentration.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Area Under the Plasma Concentration Curve From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872
AUC12h is the AUC from time of administration up to 12 hours post dosing, calculated by linear-linear trapezoidal summation.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Average Steady-state Plasma Concentration (Cavg) of JNJ-63623872
Cavg is the average steady-state plasma concentration, calculated by AUC12h / 12 hours at steady-state (12 hours = dosing interval).
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Fluctuation Index (FI) of JNJ-63623872
Fluctuation index is percentage fluctuation (variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied by ([Cmax - Cmin] / Cavg).
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Pitavastatin
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Maximum Observed Analyte Concentration (Cmax) of Pitavastatin
Cmax is the maximum observed analyte concentration.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Pitavastatin
Tmax is the actual sampling time to reach the maximum observed analyte Concentration.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Area Under the Analyte Concentration vs Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Pitavastatin
AUClast is the area under the analyte concentration vs. time curve from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
AUC From Time 0 to Infinite Time (AUC[0-infinity]) of Pitavastatin
AUC(0-infinity) is the last observed measurable (non-BQL) concentration; extrapolations of more than 20 percent (%) of the total AUC are reported as approximations.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Apparent Terminal Elimination Rate Constant (Lambda[z]) of Pitavastatin
Lambda(z) is the apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs. time curve.
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Apparent Terminal Elimination Half-life of Pitavastatin (T1/2term)
T1/2term is the apparent terminal elimination half-life, calculated as Lambda(z).
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) of Pitavastatin
Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ratio of Individual AUClast Values Between Test and Reference Treatment (Ratio AUClast,test/ref) of Pitavastatin
Ratio AUClast,test/ref is the ratio of individual AUClast values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ratio of Individual AUC[infinity] Values Between Test and Reference Treatment (Ratio AUC[infinity],test/ref) of Pitavastatin
Ratio AUC[infinity],test/ref is the ratio of individual AUC[infinity] values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9

Secondary outcomes (1)

Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: From Screening up to End of Study (up to 2 months)

Timeline

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

Nov 2015Jan 2016

First posted3 Nov 2015 (estimated)
Study startNov 2015
Primary completionJan 2016
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02595268
Sponsor's protocol ID: CR107446
Other IDs: 63623872FLZ1004, 2015-000628-27, 2015
Status last verified: Jan 2016
First submitted: 2 Nov 2015
Last updated: 27 Jan 2016
Results posted: 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 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Sequential Study to Investigate the Effect of JNJ 63623872 on Pitavastatin in Healthy Subjects
ClinicalTrials.gov ID: NCT02595268
Acronym / sponsor ID: CR107446
Conditions: Healthy
Keywords: Healthy, Pitavastatin, JNJ-63623872
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 3 Nov 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 evaluate the effect of steady-state concentrations of JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.

Detailed description

Study design

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

Arm	Type	Receives
Pitavastatin Then JNJ-63623872	Experimental	Drug: Pitavastatin, Drug: JNJ-63623872Participants will sequentially receive single oral dose of pitavastatin 1 milligram (mg) on Day 1, followed by JNJ-63623872 600 mg twice daily on Days 4 through 12 with a single oral dose of pitavastatin 1 mg administered in the morning of Day 9. All study drug intakes will be taken orally, under fed conditions (within approximately 10 minutes after completion of a meal).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
A female participant of childbearing potential must have a negative serum beta-human chorionic gonadotropin test at Screening and a negative urine pregnancy test on Day -1
A female participant must agree not to donate eggs (ova, oocytes) throughout the study and for at least 90 days after receiving the last dose of study drug
A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of birth control, and all male participants must also agree not to donate sperm throughout the study and for 90 days after receiving the last dose of study drug
Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m^2), extremes included

Key exclusion criteria (5 listed)

Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction [calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening], significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances, or a predisposition to myopathy
Participants with one or more laboratory abnormalities as specified in protocol, at Screening as defined by the World Health Organization (WHO) Toxicity Grading Scale
Participant with a past history of clinically significant heart arrhythmia (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed 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
PitavastatinParticipants will receive single oral dose of pitavastatin 1 milligram (mg) on Day 1 and Day 9.	Drug	Pitavastatin Then JNJ-63623872
JNJ-63623872Participants will receive JNJ-63623872 600 mg twice daily on Days 4 through 12.	Drug	Pitavastatin Then JNJ-63623872

Primary outcome

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
Time frame: 72 hour (hr) post-dose on Day 7, 8; predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Cmin is the minimum observed analyte concentration.
Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Cmax is the maximum observed analyte concentration.
Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-63623872
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Tmax is the actual sampling time to reach the maximum observed analyte Concentration.
Area Under the Plasma Concentration Curve From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
AUC12h is the AUC from time of administration up to 12 hours post dosing, calculated by linear-linear trapezoidal summation.
Average Steady-state Plasma Concentration (Cavg) of JNJ-63623872
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Cavg is the average steady-state plasma concentration, calculated by AUC12h / 12 hours at steady-state (12 hours = dosing interval).
Fluctuation Index (FI) of JNJ-63623872
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
Fluctuation index is percentage fluctuation (variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied by ([Cmax - Cmin] / Cavg).
Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Maximum Observed Analyte Concentration (Cmax) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Cmax is the maximum observed analyte concentration.
Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Tmax is the actual sampling time to reach the maximum observed analyte Concentration.
Area Under the Analyte Concentration vs Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
AUClast is the area under the analyte concentration vs. time curve from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
AUC From Time 0 to Infinite Time (AUC[0-infinity]) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
AUC(0-infinity) is the last observed measurable (non-BQL) concentration; extrapolations of more than 20 percent (%) of the total AUC are reported as approximations.
Apparent Terminal Elimination Rate Constant (Lambda[z]) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Lambda(z) is the apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs. time curve.
Apparent Terminal Elimination Half-life of Pitavastatin (T1/2term)
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
T1/2term is the apparent terminal elimination half-life, calculated as Lambda(z).
Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Ratio of Individual AUClast Values Between Test and Reference Treatment (Ratio AUClast,test/ref) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ratio AUClast,test/ref is the ratio of individual AUClast values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).
Ratio of Individual AUC[infinity] Values Between Test and Reference Treatment (Ratio AUC[infinity],test/ref) of Pitavastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
Ratio AUC[infinity],test/ref is the ratio of individual AUC[infinity] values between test and reference Treatment. Test is Day 9 (JNJ-63623872 plus pitavastatin) and reference is Day 1(/pitavastatin alone).

1 secondary outcome

Number of Participants With Adverse Events (AEs)
Time frame: From Screening up to End of Study (up to 2 months)

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 Jan 2016.

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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 Pitavastatin and JNJ-63623872 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 27 Jan 2016. 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?

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872 (time frame: 72 hour (hr) post-dose on Day 7, 8; predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9). 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?

On the ClinicalTrials.gov record for NCT02595268.

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 Jan 2016.