- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03618160
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Subcutaneous (SC) Injections of JNJ-64565111 in Healthy Male Japanese Participants and to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Participants
14 sierpnia 2019 zaktualizowane przez: Janssen Pharmaceutical K.K.
A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Japanese Subjects and An Open-label, Single Dose Study to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64565111 following single and multiple subcutaneous (SC) doses in healthy Japanese male participants.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
42
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Fukuoka, Japonia, 812-0025
- Souseikai Hakata Clinic
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Tokyo, Japonia, 130-0004
- Sumida Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
20 lat do 65 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Męski
Opis
Inclusion Criteria:
- For Part 1 and Part 2, participant must be a Japanese male 20 to 65 years of age, inclusive, at the time of informed consent for screening. For Part 3, participant must be a Caucasian male (defined as white and all of his parents and grandparents are white as determined by participant's verbal report) 20 to 65 years of age, inclusive, at the time of informed consent for screening
- Participant must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during sexual intercourse (even in case of prior vasectomy), or to remain abstinent, and not to donate sperm during the study and for 90 days after study drug administration. Participants should encourage their female partner to use an effective method of contraception (example, prescription oral contraceptives, contraceptive injections, intrauterine device, or contraceptive patch) in addition to the condom used by the male study participant
- Participant must have a body mass index (BMI) ranging from 25 to 40 kilogram per meter square (kg/m^2), weighing 120 kilogram (kg) or less
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
- Participant must be a non smoker for at least 1 month prior to screening. A positive urine smoking test (cotinine) at screening and/or admission (Day 2) will lead to exclusion
Exclusion Criteria:
- Participant having a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiovascular disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), significant pulmonary disease, including bronchospastic respiratory disease, hepatic or renal insufficiency, type 1 diabetes mellitus, type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, 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 result
- Participant has taken any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, from 14 days before the first dose of the study drug is scheduled until completion of the study
- Participant has received an experimental drug (including investigational vaccines) or used an experimental medical device within 3 months or within a period less than 5 times the drug's half life, whichever is longer, prior to screening
- Participant test positive for human immunodeficiency virus (HIV [positive serology for HIV antigen/antibody]), tests positive for hepatitis B virus surface antigen, or has antibodies to hepatitis C virus (HCV) at screening
- Participant has had major surgery (example, requiring general anesthesia) within 4 months before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after study drug administration
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Part 1: SAD (Cohort 1 to 3)
Participants in Cohorts 1 to 3 will receive a single Subcutaneous (SC) low, medium, and high dose of JNJ-64565111 or a JNJ-64565111 matched placebo respectively on Day 1, under fasted conditions in healthy Japanese male participants.
Doses in subsequent cohorts will be escalated based on review of Principal Investigator and the Sponsor's decision after safety, tolerability review to determine safe and maximum well tolerated dose.
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Participants in Cohorts 1 to 3 will receive a single SC low, medium, and high dose of JNJ-64565111 respectively on Day 1, participants in Cohorts 4 to 6 will receive weekly multiple SC low, high and medium dose of JNJ-64565111 respectively on Days 1, 8, 15, and 22, under fasted conditions.
Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 on Day 1, under fasted conditions.
Participants will receive SC injection of matching placebo on Day 1 in all cohorts of Part 1 and on Days 1, 8, 15, and 22 in Part 2 under fasted conditions.
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Eksperymentalny: Part 2: MAD (Cohort 4 to 6)
Participants in Cohorts 4 to 5 will receive weekly multiple SC low and high dose of JNJ-64565111 or a JNJ-64565111 matched placebo respectively on Day 1, under fasted conditions in healthy Japanese male participants.
If multiple high dose is judged as not tolerable, additional optional Cohort 6 will be added to Part 2 to investigate the safety, tolerability and PK after administration of multiple medium dose of JNJ-64565111 in healthy Japanese male participants.
Doses in subsequent cohorts will be escalated based on review of Principal Investigator and the Sponsor's decision after safety and tolerability review to determine safe and maximum well tolerated dose.
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Participants in Cohorts 1 to 3 will receive a single SC low, medium, and high dose of JNJ-64565111 respectively on Day 1, participants in Cohorts 4 to 6 will receive weekly multiple SC low, high and medium dose of JNJ-64565111 respectively on Days 1, 8, 15, and 22, under fasted conditions.
Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 on Day 1, under fasted conditions.
Participants will receive SC injection of matching placebo on Day 1 in all cohorts of Part 1 and on Days 1, 8, 15, and 22 in Part 2 under fasted conditions.
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Eksperymentalny: Part 3: Single Dose (Cohort 7)
Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 which may be started (as early as) in parallel with Cohort 3 in Part 1 on Day 1, under fasted conditions in healthy Caucasian male participants.
Based on the results from Cohort 1 to 3 in Part 1, the dose of Cohort 7 may be reduced to low dose or increased to high dose.
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Participants in Cohorts 1 to 3 will receive a single SC low, medium, and high dose of JNJ-64565111 respectively on Day 1, participants in Cohorts 4 to 6 will receive weekly multiple SC low, high and medium dose of JNJ-64565111 respectively on Days 1, 8, 15, and 22, under fasted conditions.
Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 on Day 1, under fasted conditions.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Part 1 and Part 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Ramy czasowe: Up to Day 35
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An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
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Up to Day 35
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Part 1: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Cmax is defined as the maximum observed serum concentration.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 1: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Tmax is defined as the actual sampling time to reach maximum observed serum concentration of JNJ-64565111.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 1: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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AUC(0-Last) is defined as the AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) serum concentration.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 1: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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AUC (0-infinity) is defined as the area under the serum concentration-time curve from time zero to infinite time calculated as the sum of AUC(0-last) and Clast/ lambda (z); wherein AUC(0-last) is area under the serum concentration time curve from time zero to last measurable serum concentration, Clast is the last observed measurable (non-BQL) serum concentration, and lambda (z) is the apparent terminal elimination rate constant.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 1: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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t1/2 is defined as the apparent terminal elimination half life, and is calculated as 0.693/lambda (z).
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 1: Apparent Volume of Distribution (V/F) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Apparent volume of distribution after subcutaneous dose (V/F) is influenced by the fraction absorbed and calculated as dose/(lambda (z)*AUC[0-infinity]).
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 1: Total Apparent Clearance (CL/F) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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CL/F is defined as the total apparent clearance of drug after extravascular administration calculated as: dose divided by AUC[0-infinity].
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 2: Number of Participants With AEs as a Measure of Safety and Tolerability
Ramy czasowe: Up to Day 72
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An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
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Up to Day 72
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Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111
Ramy czasowe: Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Cmax is defined as the maximum observed serum concentration.
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Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Part 2: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111
Ramy czasowe: Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Tmax is defined as the actual sampling time to reach maximum observed serum concentration of JNJ-64565111.
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Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Part 2: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111
Ramy czasowe: Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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t1/2 is defined as the apparent terminal elimination half life, and is calculated as 0.693/lambda (z).
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Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Part 2: Apparent Volume of Distribution (V/F) of JNJ-64565111
Ramy czasowe: Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Apparent volume of distribution after subcutaneous dose (V/F) is influenced by the fraction absorbed and calculated as dose/(lambda (z)*AUCtau).
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Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Part 2: Total Apparent Clearance (CL/F) of JNJ-64565111
Ramy czasowe: Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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CL/F is the total apparent clearance of drug after extravascular administration calculated as: dose divided by AUCtau.
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Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Part 2: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-64565111
Ramy czasowe: Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: 72, 96, 144, 168 hours postdose
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AUCtau is defined as the measure of the serum drug concentration from time zero to end of dosing interval.
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Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: 72, 96, 144, 168 hours postdose
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Part 2: Observed Serum Concentration Just Prior to the Beginning or the End of a Dosing Interval (Ctrough) of JNJ-64565111
Ramy czasowe: Day 8: Predose ; Day 15: Predose; Day 22: Predose, 168 hours postdose
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Ctrough is defined as the observed serum concentration just prior to the beginning or the end of a dosing interval.
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Day 8: Predose ; Day 15: Predose; Day 22: Predose, 168 hours postdose
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Part 2: Average Concentration Over the Dosing Interval Tau (T) at Steady State (Caverage,ss) of JNJ-64565111
Ramy czasowe: Day 22: Predose, 72, 96, 144, 168 hours postdose
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Caverage,ss is defined as area under the serum concentration time curve observed during a dosing interval (tau) at steady state) will be calculated as AUCtau/Tau.
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Day 22: Predose, 72, 96, 144, 168 hours postdose
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Part 2: Observed Accumulation Index (AR-AUC) of JNJ-64565111
Ramy czasowe: Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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AR-AUC is determined after multiple dose administration of JNJ-64565111 and calculated by using the equation: AUCtau, Day 22 divided by AUCtau, Day 1.
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Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Part 1 and 3: Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-64565111
Ramy czasowe: Predose, 144 and 816 hours postdose
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Number of participants with anti-drug antibodies (ADAs) to JNJ-64565111 will be reported.
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Predose, 144 and 816 hours postdose
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Part 1 and Part 3: Change From Baseline in Body Weight
Ramy czasowe: Baseline to Day 35
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Change from baseline in body weight will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change from Baseline in Fasting Plasma Glucose (FPG) Levels
Ramy czasowe: Baseline to Day 35
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Change from baseline in FPG levels will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change From Baseline in Total Cholesterol
Ramy czasowe: Baseline to Day 35
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Change from baseline in total cholesterol will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change From Baseline in Low Density Lipoprotein- Cholesterol (LDL-C)
Ramy czasowe: Baseline to Day 35
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Change from baseline in LDL-C will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Ramy czasowe: Baseline to Day 35
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Change from baseline in HDL-C will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Ramy czasowe: Baseline to Day 35
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Change from baseline in VLDL-C will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change From Baseline in Triglycerides
Ramy czasowe: Baseline to Day 35
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Change from baseline in Triglycerides will be reported.
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Baseline to Day 35
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Part 1 and Part 3: Change From Baseline in Free Fatty Acids
Ramy czasowe: Baseline to Day 35
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Change from baseline in free fatty acids will be reported.
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Baseline to Day 35
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Part 2: Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-64565111
Ramy czasowe: Predose on Day 1, 8, 15, 22 and then at 144, 480, 720, 1200 hours postdose
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Number of participants with ADAs to JNJ-64565111 will be reported.
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Predose on Day 1, 8, 15, 22 and then at 144, 480, 720, 1200 hours postdose
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Part 2: Change From Baseline in Body Weight
Ramy czasowe: Baseline to Day 72
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Change from baseline in body weight will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in Fasting Plasma Glucose (FPG) Levels
Ramy czasowe: Baseline to Day 72
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Change from baseline in FPG levels will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in Total Cholesterol
Ramy czasowe: Baseline to Day 72
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Change from baseline in total cholesterol will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in Low Density Lipoprotein- Cholesterol (LDL-C)
Ramy czasowe: Baseline to Day 72
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Change from baseline in LDL-C will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in High-Density Lipoprotein-Choelsterol (HDL-C)
Ramy czasowe: Baseline to Day 72
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Change from baseline in HDL-C will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Ramy czasowe: Baseline to Day 72
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Change from baseline in VLDL-C will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in Triglycerides
Ramy czasowe: Baseline to Day 72
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Change from baseline in triglycerides will be reported.
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Baseline to Day 72
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Part 2: Change From Baseline in Free Fatty Acids
Ramy czasowe: Baseline to Day 72
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Change from baseline in free fatty acids will be reported.
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Baseline to Day 72
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Part 3: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Cmax is defined as the maximum observed serum concentration.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Tmax is defined as the actual sampling time to reach maximum observed serum concentration of JNJ-64565111.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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AUC(0-Last) is defined as the AUC from time 0 to the time of the last measurable non-below quantification limit serum concentration.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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AUC (0-infinity) is defined as the area under the serum concentration-time curve from time zero to infinite time calculated as the sum of AUC(0-last) and Clast/ lambda (z); wherein AUC(0-last) is area under the serum concentration time curve from time zero to last measurable serum concentration, Clast is the last observed measurable (non-BQL) serum concentration, and lambda (z) is the apparent terminal elimination rate constant.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3: Apparent Terminal Elimination Rate Constant (Lambda [z]) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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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.
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3:Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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t1/2 is defined the apparent terminal elimination half life, and is calculated as 0.693/lambda (z).
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3: Apparent Volume of Distribution (V/F) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Apparent volume of distribution after subcutaneous dose (V/F) is influenced by the fraction absorbed and calculated as dose/(lambda (z)*AUC[0-infinity]).
|
Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Part 3: Total Apparent Clearance (CL/F) of JNJ-64565111
Ramy czasowe: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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CL/F is defined as the total apparent clearance of drug after extravascular administration calculated as: dose divided by AUC[0-infinity].
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Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Janssen Pharmaceutical K.K Clinical Trial, Janssen Pharmaceutical K.K.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
6 sierpnia 2018
Zakończenie podstawowe (Rzeczywisty)
21 czerwca 2019
Ukończenie studiów (Rzeczywisty)
21 czerwca 2019
Daty rejestracji na studia
Pierwszy przesłany
2 sierpnia 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
2 sierpnia 2018
Pierwszy wysłany (Rzeczywisty)
7 sierpnia 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 sierpnia 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 sierpnia 2019
Ostatnia weryfikacja
1 sierpnia 2019
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- CR108497
- 64565111NAS1001 (Inny identyfikator: Janssen Pharmaceutical K.K)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na JNJ-64565111
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Janssen Research & Development, LLCZakończony