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
27 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Maryland
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Brooklyn, Maryland, Verenigde Staten, 21225
- Research Site
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Treatment A
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state.
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Laroprovstat/ezetimibe will be administered orally.
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Experimenteel: Treatment B
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.
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Laroprovstat will be administered orally.
Ezetimibe will be administered orally.
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Experimenteel: Treatment C
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state.
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Laroprovstat/ezetimibe will be administered orally.
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Experimenteel: Treatment D
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state.
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Laroprovstat/ezetimibe slow variant will be administered orally
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Area under concentration-time curve from time 0 to infinity (AUCinf)
Tijdsspanne: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
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To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
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Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
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Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Tijdsspanne: 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)
|
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Maximum observed drug concentration (Cmax)
Tijdsspanne: 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.
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Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Plasma Time to reach maximum observed concentration (tmax)
Tijdsspanne: 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.
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Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
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Terminal elimination half-life (t½λz)
Tijdsspanne: 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)
|
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Apparent total body clearance (CL/F)
Tijdsspanne: 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)
|
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Apparent volume of distribution based on the terminal phase (Vz/F)
Tijdsspanne: 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
Tijdsspanne: 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.
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Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
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AUClast
Tijdsspanne: 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.
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Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
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Cmax
Tijdsspanne: 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)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 juni 2026
Primaire voltooiing (Geschat)
7 september 2026
Studie voltooiing (Geschat)
7 september 2026
Studieregistratiedata
Eerst ingediend
28 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 mei 2026
Eerst geplaatst (Werkelijk)
3 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D7963C00001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
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-toegangscriteria voor delen
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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