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Completed

NCT Number: NCT02860806

Safety, Tolerability, Pharmacokinetic and Absolute Bioavailability Study of JNJ-63623872 Administered as an Intravenous Infusion and a 600-Milligram (mg) Oral Dose in Healthy Adults

The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of one selected dose administered as a continuous IV infusion at various durations and to characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous infusion.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A female participant (except if postmenopausal) must have a negative serum beta- human chorionic gonadotropin (beta-hCG) pregnancy test at screening and on Day -1 of each treatment period
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after discontinuation of study drug
  • During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception in the female partner, a man regardless of having been vasectomized: 1) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository), 2) must agree not to donate sperm and 3) who is sexually active with a pregnant women must use a condom
  • Must have a Body Mass Index (BMI); weight kilogram [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (extremes included) at Screening
  • Must have a blood pressure (supine after at least 5 minutes rest and standing after at least 1 minute standing) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at Screening

Exclusion criteria

  • Has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • With a past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
  • Has known allergies, hypersensitivity, or intolerance to JNJ-63623872 or its excipients
  • With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
  • With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
  • 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
  • Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening

Treatment and study plan

JNJ-63623872

Drug

3 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered.

Placebo

Drug

Intravenous infusion of matching placebo.

Primary outcomes

  1. Maximum Observed Analyte Concentration (Cmax)

    Time frame: Up to 10 days

    The Cmax is the maximum observed analyte concentration.

  2. Fluctuation Index (FI)

    Time frame: Up to 10 days

    FI is defined as the percentage fluctuation between the Ctrough, morning analyte concentration and the maximum analyte concentration.

  3. Average Analyte Concentration (Cavg)

    Time frame: Up to 10 days

    The Cavg is an average analyte concentration at steady-state over the dosing interval.

  4. Time to Reach the Maximum Observed Analyte Concentration (Tmax)

    Time frame: Up to 10 days

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  5. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12])

    Time frame: Up to 10 days

    The (AUC [0-12]) is the area under the plasma concentration-time curve from time 0 to 12 hour post dose, calculated by linear-linear trapezoidal summation.

  6. Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last])

    Time frame: Up to 10 days

    The (AUC [0-last]) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

  7. Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

    Time frame: Up to 10 days

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(last) and C(last)/lambda(z), where Clast is the last observed measurable (non-BQL) concentration; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.

  8. Elimination Rate Constant (Lambda[z])

    Time frame: Up to 10 days

    Lambda(z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.

  9. Apparent Terminal Elimination Half-life (t1/2term)

    Time frame: Up to 10 days

    Apparent terminal elimination half-life is defined as 0.693/Lambda[z].

  10. Systemic Clearance (CL)

    Time frame: Up to 10 days

    CL is the total systemic clearance, following intravenous administration.

  11. Apparent Clearance (CL/F)

    Time frame: Up to 10 days

    CL/F is the total apparent clearance, following extravascular administration.

  12. Volume of Distribution (Vd)

    Time frame: Up to 10 days

    The Vd is defined as volume of distribution, following single dose intravenous administration.

  13. Apparent Volume of Distribution (Vd/F)

    Time frame: Up to 10 days

    Vd/F is defined as apparent volume of distribution, following single dose extravascular administration.

  14. Volume of Distribution at Steady-State (Vss)

    Time frame: Up to 10 days

    Vss is defined as apparent volume of distribution at steady-state following intravenous administration.

  15. Observed Accumulation Index (RA abs)

    Time frame: Up to 10 days

    Observed Accumulation Index is calculated by AUC12h, steady state/(AUC12h, single dose).

  16. Morning Trough Analyte Concentration (Ctrough, morning)

    Time frame: Up to 10 days

    Ctrough, morning is defined as observed analyte concentration just prior to the beginning of a dosing interval.

  17. Evening Trough Analyte Concentration (Ctrough, evening)

    Time frame: Up to 10 days

    Ctrough, evening is defined as observed analyte concentration at the end of a dosing interval.

  18. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Up to End of Study (Day 14)

Secondary outcomes

  1. Absolute Bioavailability (F[abs])

    Time frame: Up to 10 days

    The F(abs) is calculated as AUC (0-infinity), oral/ AUC (0-infinity), intravenous (iv)*Dose, iv/Dose, oral*100 %, where AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag International NV

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Absolute Bioavailability of JNJ-63623872 Administered as an Intravenous Infusion and a 600-mg Oral Dose in Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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