A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
20. juli 2026 opdateret af: AstraZeneca
A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).
In total 3 formulations will be evaluated at 2 dose levels each:
- Reference formulation
- Test formulation 1
- Test formulation 2
The study will comprise:
- A Screening Period.
- 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.
- A final Follow-up Visit.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
152
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studiesteder
-
-
California
-
Glendale, California, Forenede Stater, 91206
- Research Site
-
-
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 participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
- Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
- History of any clinically important disease or disorder.
- History of acute pancreatitis.
- History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Participants who have previously received elecoglipron within the last 3 months.
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: Cohort 1-Treatment Sequence A
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 1 - Treatment Sequence B
Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 2 - Treatment Sequence C
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 2 - Treatment Sequence D
Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 3 - Treatment Sequence E
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 3 - Treatment Sequence F
Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 4 - Treatment Sequence G
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
|
Eksperimentel: Cohort 4 - Treatment Sequence H
Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
|
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum observed drug concentration (Cmax)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Area under concentration-time curve from time 0 to infinity (AUCinf)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Time to reach maximum observed concentration (tmax)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Terminal elimination rate constant (λz)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Terminal elimination half-life (t1/2λz)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Apparent total body clearance (CL/F)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Apparent volume of distribution based on the terminal phase (Vz/F)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
|
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
Tidsramme: At pre-defined intervals from Day 1 to Day 15
|
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
|
At pre-defined intervals from Day 1 to Day 15
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with adverse events (AEs)
Tidsramme: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
|
To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.
|
From screening (Day -28) up to follow-up visit (Day 18-Day 22)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
27. juli 2026
Primær færdiggørelse (Anslået)
18. november 2026
Studieafslutning (Anslået)
18. november 2026
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D7260C00023
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
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