Clinical trial NCT02595268: A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants
Official title: A Phase 1, Open-label, Sequential Study to Investigate the Effect of JNJ 63623872 on Pitavastatin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Pitavastatin
JNJ-63623872
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872
timeFrame: 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
measure: Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
measure: Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
measure: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-63623872
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
measure: Area Under the Plasma Concentration Curve From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
measure: Average Steady-state Plasma Concentration (Cavg) of JNJ-63623872
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
measure: Fluctuation Index (FI) of JNJ-63623872
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9
measure: Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Maximum Observed Analyte Concentration (Cmax) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Area Under the Analyte Concentration vs Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: AUC From Time 0 to Infinite Time (AUC[0-infinity]) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Apparent Terminal Elimination Rate Constant (Lambda[z]) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Apparent Terminal Elimination Half-life of Pitavastatin (T1/2term)
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Ratio of Individual AUClast Values Between Test and Reference Treatment (Ratio AUClast,test/ref) of Pitavastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9
measure: Ratio of Individual AUC[infinity] Values Between Test and Reference Treatment (Ratio AUC[infinity],test/ref) of Pitavastatin
timeFrame: 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:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From Screening up to End of Study (up to 2 months)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: