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 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Brooklyn, Maryland, Forente stater, 21225
- Research Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment A
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state.
|
Laroprovstat/ezetimibe will be administered orally.
|
|
Eksperimentell: Treatment B
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.
|
Laroprovstat will be administered orally.
Ezetimibe will be administered orally.
|
|
Eksperimentell: Treatment C
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state.
|
Laroprovstat/ezetimibe will be administered orally.
|
|
Eksperimentell: Treatment D
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state.
|
Laroprovstat/ezetimibe slow variant will be administered orally
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
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Hjelpsomme linker
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
10. juni 2026
Primær fullføring (Antatt)
7. september 2026
Studiet fullført (Antatt)
7. september 2026
Datoer for studieregistrering
Først innsendt
28. mai 2026
Først innsendt som oppfylte QC-kriteriene
28. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D7963C00001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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