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

NCT02595268 | Completed Phase 1

• 3 other identifiers: CR10744663623872FLZ10042015-000628-27
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Pitavastatin; JNJ-63623872

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  From Screening up to End of Study (up to 2 months)

Study Arms (1)

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).

Drug: Pitavastatin; Drug: JNJ-63623872

Interventions

Pitavastatin DRUG

Participants will receive single oral dose of pitavastatin 1 milligram (mg) on Day 1 and Day 9.

Pitavastatin Then JNJ-63623872

JNJ-63623872 DRUG

Participants will receive JNJ-63623872 600 mg twice daily on Days 4 through 12.

Pitavastatin Then JNJ-63623872

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

pitavastatin; pimodivir

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

BE (1)