- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04782661
A Study of JNJ-70075200 in Healthy Participants
14 grudnia 2021 zaktualizowane przez: Janssen Research & Development, LLC
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).
Przegląd badań
Typ studiów
Interwencyjne
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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Groningen, Holandia, 9728 NZ
- PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
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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
18 lat do 55 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion criteria:
- Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
- Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
- No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
- Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m^2) (BMI = weight/height^2) (inclusive)
- All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening
Exclusion criteria:
- Participants having a history of liver or renal insufficiency (estimated creatinine clearance [CL] below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) for males, and >470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
- Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2
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: Single Ascending Dose (SAD)
Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition.
Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days.
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Roztwór placebo będzie podawany doustnie.
JNJ-70075200 solution or solid formulations will be administered orally.
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Eksperymentalny: Part 2: Multiple Ascending Dose (MAD)
After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition.
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Roztwór placebo będzie podawany doustnie.
JNJ-70075200 solution or solid formulations will be administered orally.
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Eksperymentalny: Part 3: Single-dose Oral Solid Formulation (Optional)
Participants will receive oral dose of JNJ-70075200 on Day 1 in Cohort 1 under fasted condition.
Part 3 will start after obtaining a formal regulatory/ethical approval.
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JNJ-70075200 solution or solid formulations will be administered orally.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Ramy czasowe: Up to 1 year and 1 month
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to 1 year and 1 month
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Percentage of Participants with Serious Adverse Events (SAEs)
Ramy czasowe: Up to 1 year and 1 month
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Up to 1 year and 1 month
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Number of Participants with Clinically Significant Changes in Vital Signs
Ramy czasowe: Up to 1 year and 1 month
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Number of participants with clinically significant changes in vital signs will be assessed.
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Up to 1 year and 1 month
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Number of Participants with Clinically Significant Changes in Physical Examination
Ramy czasowe: Up to 1 year and 1 month
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Number of participants with clinically significant changes in physical examination will be assessed.
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Up to 1 year and 1 month
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Number of Participants With Clinically Significant Laboratory Abnormalities
Ramy czasowe: Up to 1 year and 1 month
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Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
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Up to 1 year and 1 month
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Change From Baseline in QTc Interval
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
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Baseline, up to 1 year and 1 month
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Change from Baseline in Heart Rate (HR)
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in HR will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change from Baseline in QRS Interval
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in QRS interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change from Baseline in PR Interval
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in PR interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change From Baseline in QT Interval
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in QT interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time
Ramy czasowe: Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
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Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
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Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
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Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)
Ramy czasowe: Predose, up to 72 hours postdose (up to Day 4)
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Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS.
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Predose, up to 72 hours postdose (up to Day 4)
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Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)
Ramy czasowe: Up to 1 year and 1 month
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to 1 year and 1 month
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Part 1 and 3: Percentage of Participants with SAEs (Food Effect)
Ramy czasowe: Up to 1 year and 1 month
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)
Ramy czasowe: Up to 1 year and 1 month
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Number of participants with clinically significant changes in vital signs will be assessed.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)
Ramy czasowe: Up to 1 year and 1 month
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Number of participants with clinically significant changes in physical examination will be assessed.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)
Ramy czasowe: Up to 1 year and 1 month
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Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
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Up to 1 year and 1 month
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Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in QTc interval using Fridericia method will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in HR (Food Effect)
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in HR will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in QRS interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in PR interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)
Ramy czasowe: Baseline, up to 1 year and 1 month
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Change from baseline in QT interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
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 (Oczekiwany)
1 marca 2022
Zakończenie podstawowe (Oczekiwany)
9 maja 2022
Ukończenie studiów (Oczekiwany)
23 września 2022
Daty rejestracji na studia
Pierwszy przesłany
16 lutego 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 marca 2021
Pierwszy wysłany (Rzeczywisty)
4 marca 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 stycznia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 grudnia 2021
Ostatnia weryfikacja
1 grudnia 2021
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- CR108971
- 2020-004946-12 (Numer EudraCT)
- 70075200SLE1001 (Inny identyfikator: Janssen Research & Development, LLC)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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 .
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