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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595268
• Other study ID #: CR107446
• Secondary ID: 63623872FLZ10042
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2015
• Last updated: January 26, 2016
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Primary	Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872	Cmin is the minimum observed analyte concentration.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9	No
Primary	Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872	Cmax is the maximum observed analyte concentration.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9	No
Primary	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.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9	No
Primary	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.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9	No
Primary	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).	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9	No
Primary	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).	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 9	No
Primary	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.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	Maximum Observed Analyte Concentration (Cmax) of Pitavastatin	Cmax is the maximum observed analyte concentration.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Pitavastatin	Tmax is the actual sampling time to reach the maximum observed analyte Concentration.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	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.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	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.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	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.	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	Apparent Terminal Elimination Half-life of Pitavastatin (T1/2term)	T1/2term is the apparent terminal elimination half-life, calculated as Lambda(z).	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	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).	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	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).	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Primary	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).	predose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16 hr post-dose on Day 1 and Day 9	No
Secondary	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.	From Screening up to End of Study (up to 2 months)	Yes