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A Study of JNJ-70075200 in Healthy Participants

14. desember 2021 oppdatert av: 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).

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Nederland
      • Groningen, Nederland, 9728 NZ
        • PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Placebo
Placeboløsning vil bli administrert oralt.
Legemiddel: JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.
Eksperimentell: 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.
Legemiddel: Placebo
Placeboløsning vil bli administrert oralt.
Legemiddel: JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.
Eksperimentell: 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.
Legemiddel: JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 1 year and 1 month
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.
Up to 1 year and 1 month
Percentage of Participants with Serious Adverse Events (SAEs)
Tidsramme: Up to 1 year and 1 month
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.
Up to 1 year and 1 month
Number of Participants with Clinically Significant Changes in Vital Signs
Tidsramme: Up to 1 year and 1 month
Number of participants with clinically significant changes in vital signs will be assessed.
Up to 1 year and 1 month
Number of Participants with Clinically Significant Changes in Physical Examination
Tidsramme: Up to 1 year and 1 month
Number of participants with clinically significant changes in physical examination will be assessed.
Up to 1 year and 1 month
Number of Participants With Clinically Significant Laboratory Abnormalities
Tidsramme: Up to 1 year and 1 month
Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
Up to 1 year and 1 month
Change From Baseline in QTc Interval
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
Baseline, up to 1 year and 1 month
Change from Baseline in Heart Rate (HR)
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in HR will be measured by ECG.
Baseline, up to 1 year and 1 month
Change from Baseline in QRS Interval
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in QRS interval will be measured by ECG.
Baseline, up to 1 year and 1 month
Change from Baseline in PR Interval
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in PR interval will be measured by ECG.
Baseline, up to 1 year and 1 month
Change From Baseline in QT Interval
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in QT interval will be measured by ECG.
Baseline, up to 1 year and 1 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time
Tidsramme: 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)
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).
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)
Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)
Tidsramme: Predose, up to 72 hours postdose (up to Day 4)
Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS.
Predose, up to 72 hours postdose (up to Day 4)
Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)
Tidsramme: 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)
Tidsramme: Up to 1 year and 1 month
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.
Up to 1 year and 1 month
Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)
Tidsramme: Up to 1 year and 1 month
Number of participants with clinically significant changes in vital signs will be assessed.
Up to 1 year and 1 month
Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)
Tidsramme: Up to 1 year and 1 month
Number of participants with clinically significant changes in physical examination will be assessed.
Up to 1 year and 1 month
Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)
Tidsramme: Up to 1 year and 1 month
Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
Up to 1 year and 1 month
Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in QTc interval using Fridericia method will be measured by ECG.
Baseline, up to 1 year and 1 month
Part 1 and Part 3: Change from Baseline in HR (Food Effect)
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in HR will be measured by ECG.
Baseline, up to 1 year and 1 month
Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in QRS interval will be measured by ECG.
Baseline, up to 1 year and 1 month
Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in PR interval will be measured by ECG.
Baseline, up to 1 year and 1 month
Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)
Tidsramme: Baseline, up to 1 year and 1 month
Change from baseline in QT interval will be measured by ECG.
Baseline, up to 1 year and 1 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. mars 2022

Primær fullføring (Forventet)

9. mai 2022

Studiet fullført (Forventet)

23. september 2022

Datoer for studieregistrering

Først innsendt

16. februar 2021

Først innsendt som oppfylte QC-kriteriene

3. mars 2021

Først lagt ut (Faktiske)

4. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. januar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. desember 2021

Sist bekreftet

1. desember 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CR108971
  • 2020-004946-12 (EudraCT-nummer)
  • 70075200SLE1001 (Annen identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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