Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Analyte Concentration (Cmax)
timeFrame: Up to 10 days
measure: Fluctuation Index (FI)
timeFrame: Up to 10 days
measure: Average Analyte Concentration (Cavg)
timeFrame: Up to 10 days
measure: Time to Reach the Maximum Observed Analyte Concentration (Tmax)
timeFrame: Up to 10 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12])
timeFrame: Up to 10 days
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last])
timeFrame: Up to 10 days
measure: Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: Up to 10 days
measure: Elimination Rate Constant (Lambda[z])
timeFrame: Up to 10 days
measure: Apparent Terminal Elimination Half-life (t1/2term)
timeFrame: Up to 10 days
measure: Systemic Clearance (CL)
timeFrame: Up to 10 days
measure: Apparent Clearance (CL/F)
timeFrame: Up to 10 days
measure: Volume of Distribution (Vd)
timeFrame: Up to 10 days
measure: Apparent Volume of Distribution (Vd/F)
timeFrame: Up to 10 days
measure: Volume of Distribution at Steady-State (Vss)
timeFrame: Up to 10 days
measure: Observed Accumulation Index (RA abs)
timeFrame: Up to 10 days
measure: Morning Trough Analyte Concentration (Ctrough, morning)
timeFrame: Up to 10 days
measure: Evening Trough Analyte Concentration (Ctrough, evening)
timeFrame: Up to 10 days
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to End of Study (Day 14)
Secondary outcomes:
measure: Absolute Bioavailability (F[abs])
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: