Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis

17. september 2026 opdateret af: Hoffmann-La Roche

A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

25

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Undersøgelse Kontakt Backup

  • Navn: Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below.
  • Telefonnummer: 888-662-6728 (U.S. Only)
  • E-mail: global-roche-genentech-trials@gene.com

Studiesteder

  • Belgien
      • Leuven, Belgien, 3000
        • Rekruttering
        • UZ Leuven Gasthuisberg
      • Roeselare, Belgien, 8800
        • Rekruttering
        • AZ Delta (Campus Rumbeke)
  • Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige, L7 8XP
        • Rekruttering
        • Royal Liverpool University Hospital
      • London, Det Forenede Kongerige, W1T 7HA
        • Rekruttering
        • University College London Hospitals
      • Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
        • Rekruttering
        • Royal Victoria Infirmary
  • Forenede Stater
    • California
      • Chula Vista, California, Forenede Stater, 91910
        • Rekruttering
        • Erick H. Alayo Medical Corporation - Gastro SB Clinic
    • Florida
      • Miami, Florida, Forenede Stater, 33155
        • Rekruttering
        • Allied Biomedical Research Institute, Inc
      • Miami, Florida, Forenede Stater, 33176-2416
        • Rekruttering
        • Gastro Health Research
  • Polen
      • Bydgoszcz, Polen, 85-229
        • Rekruttering
        • Centrum Medyczne "Medis"
      • Lodz, Polen, 91-495
        • Rekruttering
        • Amicare Sp. z o.o. S.K.
      • Lublin, Polen, 20-582
        • Rekruttering
        • Medrise sp z o.o
      • Nowy Targ, Polen, 34-400
        • Rekruttering
        • Allmedica Badania Kliniczne Sp z o.o. Sp K.
      • Pabianice, Polen, 92-500
        • Rekruttering
        • NZOZ Eskulap Pabianice
      • Późna, Polen, 60-529
        • Rekruttering
        • SOLUMED Centrum Medyczne
      • Warsaw, Polen, 02-507
        • Rekruttering
        • Centralny Szpital Kliniczny MSW w Warszawie
      • Warsaw, Polen, 04-501
        • Rekruttering
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroc?aw, Polen, 52-210
        • Rekruttering
        • PlanetMed sp. z o.o.
  • Tyskland
      • Berlin, Tyskland, 10117
        • Rekruttering
        • Charite Research Organisation GmbH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Body weight >= 40kg
  • Agreement to adhere to the contraceptive requirements

UC Specific Inclusion Criteria:

  • Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence
  • Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending >=15 cm from the anal verge
  • Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy

Exclusion Criteria:

Inflammatory Bowel Disease (IBD) Exclusion Criteria:

  • Current diagnosis of Crohn's disease (CD),abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
  • Presence of an ostomy or ileoanal pouch
  • Current diagnosis or suspicion of primary sclerosing cholangitis

Medical History Exclusion Criteria:

  • Lack of peripheral venous access
  • Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
  • History of alcohol, drug, or chemical abuse < 1 year prior to screening

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
Medicin: Afimkibart
Afimkibart vil blive administreret i henhold til den tidsplan, der er defineret i protokollen.
Andre navne:
  • RVT-3101
  • PF-06480605
  • RO7790121
Medicin: Caffeine
Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Medicin: Warfarin
Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Medicin: Omeprazole
Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Medicin: Dextromethorphan
Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Medicin: Midazolam
Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Andet: Vitamin K
Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Maximum Plasma Concentration (Cmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Time to Maximum Concentration (Tmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Elimination Half-life (T1/2) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Metabolite-to-parent Area Under the Curve From Time 0 (AUC0-t) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Metabolite-to-parent Area Under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks
Metabolite-to-parent Concentration of CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)
Tidsramme: Up to approximately 13 weeks
Up to approximately 13 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Procentdel af deltagere med bivirkninger (AES)
Tidsramme: Op til cirka 5 år
Op til cirka 5 år
Predose and Peak Serum Concentration of Afimkibart
Tidsramme: Up to approximately 5 years
Up to approximately 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. juni 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

19. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GA46438
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524060-38-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner