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A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults

3. juni 2026 opdateret af: AstraZeneca

A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults

The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, open-label, 4-period, single-dose, cross-over study.

The study will comprise of a screening period, 4 treatment periods, and 3 washout periods. The following treatments will be given during the study:

  • Treatment A: laroprovstat/ezetimibe fixed combination drug product (FCDP) test formulation in fasted state
  • Treatment B: laroprovstat tablet plus ezetimibe reference formulations in fasted state
  • Treatment C: laroprovstat/ezetimibe FCDP test formulation in fed state
  • Treatment D: laroprovstat/ezetimibe FCDP test formulation-slow variant in fasted state

Participants will be randomly assigned to either of the 3 treatment sequences: ABCD, BCAD, or CABD.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

18

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Maryland
      • Brooklyn, Maryland, Forenede Stater, 21225
        • Research 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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Healthy male and female participants aged 18 to 55 years at the time of signing consent.
  • All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
  • Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
  • Have a Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.

Exclusion Criteria:

  • History of any clinically important disease or disorder.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe.
  • Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.
  • Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit or inclisiran at any time.

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
Eksperimentel: Treatment A
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state.
Medicin: Laroprovstat/ezetimibe FCDP
Laroprovstat/ezetimibe will be administered orally.
Eksperimentel: Treatment B
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.
Medicin: Laroprovstat STP
Laroprovstat will be administered orally.
Medicin: Ezetimibe STP
Ezetimibe will be administered orally.
Eksperimentel: Treatment C
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state.
Medicin: Laroprovstat/ezetimibe FCDP
Laroprovstat/ezetimibe will be administered orally.
Eksperimentel: Treatment D
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state.
Medicin: Laroprovstat/ezetimibe FCDP-slow variant
Laroprovstat/ezetimibe slow variant will be administered orally

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under concentration-time curve from time 0 to infinity (AUCinf)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Maximum observed drug concentration (Cmax)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma Time to reach maximum observed concentration (tmax)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the pharmacokinetic (PK) profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Terminal elimination half-life (t½λz)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent total body clearance (CL/F)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent volume of distribution based on the terminal phase (Vz/F)
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUCinf
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUClast
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Cmax
Tidsramme: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

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 (Anslået)

10. juni 2026

Primær færdiggørelse (Anslået)

7. september 2026

Studieafslutning (Anslået)

7. september 2026

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D7963C00001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingsadgangskriterier

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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 .

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