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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02860806
• Date of registration: 05/08/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: 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
• Scientific 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
• Date of first enrolment: August 8, 2016
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02860806
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Janssen-Cilag International NV Clinical Trial
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-63623872

Drug: Placebo

Primary Outcome(s)

Fluctuation Index (FI) [Time Frame: Up to 10 days]

Evening Trough Analyte Concentration (Ctrough, evening) [Time Frame: Up to 10 days]

Morning Trough Analyte Concentration (Ctrough, morning) [Time Frame: Up to 10 days]

Apparent Terminal Elimination Half-life (t1/2term) [Time Frame: Up to 10 days]

Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) [Time Frame: Up to 10 days]

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12]) [Time Frame: Up to 10 days]

Apparent Clearance (CL/F) [Time Frame: Up to 10 days]

Apparent Volume of Distribution (Vd/F) [Time Frame: Up to 10 days]

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]

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [Time Frame: Up to End of Study (Day 14)]

Average Analyte Concentration (Cavg) [Time Frame: Up to 10 days]

Elimination Rate Constant (Lambda[z]) [Time Frame: Up to 10 days]

Maximum Observed Analyte Concentration (Cmax) [Time Frame: Up to 10 days]

Volume of Distribution (Vd) [Time Frame: Up to 10 days]

Systemic Clearance (CL) [Time Frame: Up to 10 days]

Observed Accumulation Index (RA abs) [Time Frame: Up to 10 days]

Volume of Distribution at Steady-State (Vss) [Time Frame: Up to 10 days]

Time to Reach the Maximum Observed Analyte Concentration (Tmax) [Time Frame: Up to 10 days]

Secondary Outcome(s)

Absolute Bioavailability (F[abs]) [Time Frame: Up to 10 days]

Secondary ID(s)

63623872FLZ1002

CR108196

2016-000921-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors