- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04033458
A Study of JNJ-64140284 Solid Dose Formulations in Healthy Male Participants
9. januar 2020 oppdatert av: Janssen Research & Development, LLC
A Randomized, Open-Label, 5-way Crossover Study in Healthy Male Participants to Evaluate the Bioavailability, Food Effect, Safety and Tolerability of Two Oral Solid Dosage Formulations Relative to an Oral Solution Formulation of JNJ-64140284.
The purpose of this study is to compare the pharmacokinetic profile of a single dose of two solid dosage formulations relative to a reference formulation (solution in polyethylene glycol-400 [PEG-400]) of JNJ-64140284 in healthy male participants under fasting condition and to assess the effect of food on the bioavailability of two solid dosage formulations of JNJ-64140284.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
1
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Merksem, Belgia, 2170
- Clinical Pharmacology Unit
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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 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Body Mass Index (BMI) between 18.0 and 29.9 kilograms per square meter (kg/m^2) inclusive
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase. 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 according to the investigator. This determination must be recorded in the participant's source documents and initialed by the investigator
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) (means of triplicate ECG, inclusive QTcF less than or equal to [<=] 450 milliseconds [msec]) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of left bundle branch block (LBBB), atrioventricular (AV) block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
- Non-smokers (not smoked cigarettes or equivalent or not used nicotine-based products for 3 months prior to screening)
- Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control for example, either condom or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for the duration of the study plus 3 months after receiving the last dose of study drug, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an additional method of birth control (which may include a hormonal method, an intrauterine device [IUD] or an intrauterine system [IUS]) for at least the same duration. Men with a partner who is pregnant, you must use a condom to avoid exposure to the unborn child
Exclusion Criteria:
- History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
- Participant has a history of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before Screening or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission
- Drinks, on average, more than 5 cups of tea or coffee or 8 cans of cola per day
- Clinically significant acute illness within 7 days prior to study drug administration
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Treatment Sequence ABECD
Participants will receive single oral dose of JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 2 in fasted condition (Treatment B), then JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) and, then JNJ-64140284 Regimen 4 in fed condition (Treatment D) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
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Participants will receive JNJ-64140284 orally.
Andre navn:
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Eksperimentell: Treatment Sequence BCADE
Participants will receive single oral dose of JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) then JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) and, then JNJ-64140284 Regimen 5 in fed condition (Treatment E) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
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Participants will receive JNJ-64140284 orally.
Andre navn:
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Eksperimentell: Treatment Sequence CDBEA
Participants will receive single oral dose of JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) then, JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) and then, JNJ-64140284 Regimen 1 in fasted condition (Treatment A) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
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Participants will receive JNJ-64140284 orally.
Andre navn:
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Eksperimentell: Treatment Sequence DECAB
Participants will receive single oral dose of JNJ-64140284 Regimen 4 in fed condition (Treatment D) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) then JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regiment 1 in fasted condition (Treatment A) and then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
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Participants will receive JNJ-64140284 orally.
Andre navn:
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Eksperimentell: Treatment Sequence EADBC
Participants will receive single oral dose of JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 1 in fasted condition (Treatment A) then JNJ-64140284 Regimen 4 in fed condition (Treatment D) then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) and then, JNJ-64140284 Regimen 3 in fed condition (Treatment C) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
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Participants will receive JNJ-64140284 orally.
Andre navn:
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Eksperimentell: Treatment Sequence DCEBA
Participants will receive single oral dose of JNJ-64140284 Regimen 4 in fed condition (Treatment D) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) then JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 2 in fasted condition (Treatment B) and then JNJ-64140284 Regimen 1 in fasted condition (Treatment A) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
|
Participants will receive JNJ-64140284 orally.
Andre navn:
|
Eksperimentell: Treatment Sequence EDACB
Participants will receive single oral dose of JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) then JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) and then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
|
Participants will receive JNJ-64140284 orally.
Andre navn:
|
Eksperimentell: Treatment Sequence AEBDC
Participants will receive single oral dose of JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) and then JNJ-64140284 Regimen 3 in fed condition (Treatment C) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
|
Participants will receive JNJ-64140284 orally.
Andre navn:
|
Eksperimentell: Treatment Sequence BACED
Participants will receive single oral dose of JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 1 in fasted condition (Treatment A) then JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) and then JNJ-64140284 Regimen 4 in fed condition (Treatment D) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
|
Participants will receive JNJ-64140284 orally.
Andre navn:
|
Eksperimentell: Treatment Sequence CBDAE
Participants will receive single oral dose of JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regimen 2 in fasted condition (Treatment B) then JNJ-64140284 Regimen 4 in fed condition (Treatment D) followed by JNJ-64140284 Regimen 1 in fasted condition (Treatment A) and then JNJ-64140284 Regimen 5 in fed condition (Treatment E) in Treatment Periods 1 to 5 respectively.
All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.
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Participants will receive JNJ-64140284 orally.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Peak Plasma Concentration (Cmax) of JNJ-64140284
Tidsramme: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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Cmax is defined as the peak plasma concentration of JNJ-64140284.
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Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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Area Under The Plasma Concentration-time Curve From 0 to t Hours Postdosing (AUC[0-t]) of JNJ-64140284
Tidsramme: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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AUC(0-t) is defined as the area under the plasma concentration-time curve from 0 to t hours postdosing of JNJ-64140284 (time t is the time of the last quantifiable concentration [Clast]).
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Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of JNJ-64140284
Tidsramme: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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AUC(0-inf) is defined as the area under plasma concentration-time from time 0 to infinity extrapolated to infinity of JNJ-64140284.
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Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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Relative Bioavailability (F[rel]) of JNJ-64140284
Tidsramme: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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F(rel) is defined as the relative bio-availability of JNJ-64140284 calculated as individual Cmax and AUC treatment ratio's (for the comparison of the capsule [solid 5 micro-meter (mcm) or solid 31 mcm] to the solution and for the comparison of fed versus fasted for the capsule [both for solid 5 mcm and solid 31 mcm]).
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Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Tidsramme: Up to 13 weeks
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Up to 13 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Faktiske)
29. juli 2019
Primær fullføring (Faktiske)
1. august 2019
Studiet fullført (Faktiske)
1. august 2019
Datoer for studieregistrering
Først innsendt
24. juli 2019
Først innsendt som oppfylte QC-kriteriene
24. juli 2019
Først lagt ut (Faktiske)
26. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CR108648
- 2019-001975-35 (EudraCT-nummer)
- 64140284EDI1004 (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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