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Sikkerhed, tolerabilitet og farmakokinetik af enkeltdoser BI 425809

8. maj 2026 opdateret af: Boehringer Ingelheim

Sikkerhed, tolerabilitet og farmakokinetik af enkelt stigende orale doser af BI 425809 hos raske mandlige forsøgspersoner (delvist randomiserede, enkeltblindede, placebokontrollerede) og undersøgelse af relativ biotilgængelighed og fødevareeffekt af BI 425809 (åbent, randomiseret, tre- måde crossover)

At undersøge sikkerhed, tolerabilitet og farmakokinetik af BI 425809 efter enkelte stigende doser af BI 425809 hos raske mandlige frivillige; At undersøge dosisproportionaliteten af ​​BI 425809 som oral drikkeopløsning; For at undersøge den relative biotilgængelighed af BI 425809 oral drikkeopløsning fastet sammenlignet med BI 425809 fastende og tabletfodret

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

83

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Tyskland
      • Ingelheim, Tyskland
        • 1346.1.1 Boehringer Ingelheim Investigational Site

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

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Sunde mandlige emner
  • Alder 18 til 45 år (inkl.)
  • Kropsmasseindeks (BMI) 18,5 til 29,9 kg/m2 (inkl.)
  • Faget skal kunne forstå og overholde studiekrav

Ekskluderingskriterier:

  • Ethvert fund i den medicinske undersøgelse (inklusive blodtryk (BP), pulsfrekvens (PR) eller elektrokardiogram (EKG)), der afviger fra det normale og vurderes klinisk relevant af investigator
  • Gentagen måling af systolisk blodtryk <90 eller >140 mmHg, eller diastolisk blodtryk <50 eller >90 mmHg, eller pulsfrekvens <50 eller >90
  • Enhver laboratorieværdi uden for referenceområdet, som investigator anser for at være af klinisk relevans
  • Ethvert bevis på en samtidig sygdom vurderet som klinisk relevant af investigator
  • Gastrointestinale, lever-, nyre-, respiratoriske, kardiovaskulære, metaboliske, immunologiske eller hormonelle lidelser
  • Kirurgi i mave-tarmkanalen, der kunne interferere med kinetikken af ​​undersøgelseslægemidlet/-stofferne
  • Sygdomme i centralnervesystemet (såsom epilepsi), andre neurologiske lidelser eller psykiatriske lidelser

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: SRD Part: Placebo
Participants received a single dose of oral solution of placebo matching BI 425809. SRD = Single Rising Dose.
Medicin: Placebo PfOS
Placebo as a powder for an oral solution (PfOS)
Eksperimentel: SRD Part: 0.5 mg BI 425809
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 1 mg BI 425809
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 2 mg BI 425809
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 5 mg BI 425809
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 10 mg BI425809
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 25 mg BI 425809
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 50 mg BI 425809
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 100 mg BI 425809
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Eksperimentel: BA/FE Part: 25 mg BI 425809, R/T1/T2
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Medicin: BI 425809 tablet
BI 425809 as a tablet
Andre navne:
  • Iclepertin
Eksperimentel: BA/FE Part: 25 mg BI 425809, R/T2/T1
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Medicin: BI 425809 tablet
BI 425809 as a tablet
Andre navne:
  • Iclepertin
Eksperimentel: BA/FE Part: 25 mg BI 425809, T1/T2/R
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Medicin: BI 425809 tablet
BI 425809 as a tablet
Andre navne:
  • Iclepertin
Eksperimentel: BA/FE Part: 25 mg BI 425809, T1/R/T2
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Medicin: BI 425809 tablet
BI 425809 as a tablet
Andre navne:
  • Iclepertin
Eksperimentel: BA/FE Part: 25 mg BI 425809, T2/T1/R
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Medicin: BI 425809 tablet
BI 425809 as a tablet
Andre navne:
  • Iclepertin
Eksperimentel: BA/FE Part: 25 mg BI 425809, T2/R/T1
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Medicin: BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Andre navne:
  • Iclepertin
Medicin: BI 425809 tablet
BI 425809 as a tablet
Andre navne:
  • Iclepertin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Drug-related Adverse Events (AE)
Tidsramme: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.
Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.
SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
Tidsramme: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
Tidsramme: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
Tidsramme: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
Tidsramme: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

Efterforskere

  • Studiestol: Boehringer Ingelheim, Boehringer Ingelheim

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.

Generelle publikationer

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)

20. marts 2014

Primær færdiggørelse (Faktiske)

10. september 2014

Studieafslutning (Faktiske)

10. september 2014

Datoer for studieregistrering

Først indsendt

20. februar 2014

Først indsendt, der opfyldte QC-kriterier

20. februar 2014

Først opslået (Anslået)

21. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1346.1
  • 2013-004937-34 (EudraCT nummer: EudraCT)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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 .

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