- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04782661
A Study of JNJ-70075200 in Healthy Participants
14. Dezember 2021 aktualisiert von: 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).
Studienübersicht
Status
Zurückgezogen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Groningen, Niederlande, 9728 NZ
- PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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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Placebo-Lösung wird oral verabreicht.
JNJ-70075200 solution or solid formulations will be administered orally.
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Experimental: 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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Placebo-Lösung wird oral verabreicht.
JNJ-70075200 solution or solid formulations will be administered orally.
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 1 year and 1 month
|
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.
|
Up to 1 year and 1 month
|
Part 1 and 3: Percentage of Participants with SAEs (Food Effect)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. März 2022
Primärer Abschluss (Voraussichtlich)
9. Mai 2022
Studienabschluss (Voraussichtlich)
23. September 2022
Studienanmeldedaten
Zuerst eingereicht
16. Februar 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. März 2021
Zuerst gepostet (Tatsächlich)
4. März 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Januar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. Dezember 2021
Zuletzt verifiziert
1. Dezember 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CR108971
- 2020-004946-12 (EudraCT-Nummer)
- 70075200SLE1001 (Andere Kennung: Janssen Research & Development, LLC)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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