- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03189498
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function
A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Subjects With Various Degrees of Renal Function
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Kiel, Tyskland
- CRS Clinical Research Services Kiel
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München, Tyskland, 81241
- APEX GmbH
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
- Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol
Participants with normal renal function (Group 1):
-Participant must have an estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute (mL/min)
Participants with renal impairment (Groups 2 to 4):
- The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to [>=] 60 to less than [<] 90 mL/min), Moderate renal impairment (eGFR >= 30 to <60 mL/min), Severe renal impairment (eGFR >=15 to <30 mL/min)
Participants with end-stage renal disease (ESRD) with or without hemodialysis (Group 5):
- Participant must have an eGFR <15 mL/min if not on hemodialysis
- Participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening
Exclusion Criteria:
All participants (Groups 1 to 5):
- Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment
- Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients
- Participants with evidence of an active infection
- Participant is a woman who is pregnant or breastfeeding
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Group 1: Participants With Normal Renal Function
Adult participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute [mL/min]) will receive a single oral dose of 1,000 milligram (mg) JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period.
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All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
Andre navn:
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Eksperimentell: Group 2: Participants With Mild Renal Impairment
Adult participants with mild impaired renal function (eGFR >=60 to less than [<] 90 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period.
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All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
Andre navn:
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Eksperimentell: Group 3: Participants With Moderate Renal Impairment
Adult participants with moderate impaired renal function (eGFR >=30 to <60 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period.
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All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
Andre navn:
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Eksperimentell: Group 4: Participants With Severe Renal Impairment
Adult participants with severe impaired renal function (eGFR >= 15 to <30 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period.
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All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
Andre navn:
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Eksperimentell: Group 5: Participants With ESRD With or Without Hemodialysis
Adult participants with end-stage renal disease (ESRD) (eGFR <15 mL/min if not on hemodialysis or requiring hemodialysis treatment for at least 3 months before screening if on hemodialysis) will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250-mg tablets) on Day 1 of treatment period.
Participants with ESRD on hemodialysis will be dosed on an interdialysis day within 24 hours of their last hemodialysis treatment.
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All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Maximum Observed Plasma Concentration (Cmax)
Tidsramme: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
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The Cmax is the maximum observed plasma concentration.
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Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
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Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last])
Tidsramme: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
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The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.
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Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
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Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Tidsramme: Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) 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 20 to 28 days after study drug intake (approximately 5 months)
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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 20 to 28 days after study drug intake (approximately 5 months)
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR108333
- 2017-000875-10 (EudraCT-nummer)
- 64041575RSV1006 (Annen identifikator: Janssen Pharmaceutica N.V., Belgium)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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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Kliniske studier på JNJ-64041575
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