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A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years Fase 1 64

Rekruterend
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De klinische studie NCT07455825 onderzoekt behandeling bij Gezonde deelnemers. Deze Fase 1 interventioneel-studie heeft de status rekruterend. Het doel is om 64 deelnemers te includeren vanaf 5 maart 2026. De studie wordt geleid door AstraZeneca en de voltooiing is gepland op 1 juni 2026. Laatste update op ClinicalTrials.gov: 12 maart 2026.
Beknopte samenvatting
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.
Uitgebreide beschrijving
This is a Phase I, randomized, single-dose, 2 part, 3-period, open-label study.

There will be 2 Parts (Part A and Part B). In each part, participants will be randomized to a treatment sequence in each cohort. In Period 1, participants in Part A and Part B will receive Regimen A (AZD5004 Formulation 1 \[reference\]). In Periods 2 and 3, participants in Part A will receive Regimen B or Regimen C (AZD5004 Formulation 5...

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Officiële titel

A Phase I, Randomized, Single-dose, 3-Period, Open-Label Study to Assess the Pharmacokinetic Formulation Bridging, Safety, and Food Effect of Different Oral Formulations of AZD5004 in Healthy Participants

Aandoeningen
Gezonde deelnemers
Andere studie-ID's
  • D7260C00008
NCT-ID
NCT07455825
Startdatum (Werkelijk)
2026-03-05
Laatste update geplaatst
2026-03-12
Verwachte einddatum
2026-06-01
Inschrijving (Geschat)
64
Studietype
Interventioneel
FASE
Fase 1
Status
Rekruterend
Trefwoorden
Glucagon-like peptide-1 receptor agonist
Anti-hyperglycemic
Pharmacokinetics (PK)
Oral formulations
Formulation bridging
Weight management
Type 2 Diabetes Mellitus
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelCohort A: Treatment Sequence ABC
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen B (formulation 5, fasted state), followed by Regimen C (formulation 5, fed state) of AZD5004.
AZD5004
AZD5004 will be administered orally.
ExperimenteelCohort A: Treatment Sequence ACB
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen C (formulation 5, fed state), followed by Regimen B (formulation 5, fasted state) of AZD5004.
AZD5004
AZD5004 will be administered orally.
ExperimenteelCohort B: Treatment Sequence ADE
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen D (formulation 6, fasted state), followed by Regimen E (formulation 6, fed state).
AZD5004
AZD5004 will be administered orally.
ExperimenteelCohort B: Treatment Sequence AED
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen E (formulation 6, fed state), followed by Regimen D (formulation 6, fasted state).
AZD5004
AZD5004 will be administered orally.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)
To evaluate the PK (AUCinf) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)
To evaluate the PK (AUClast) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Maximum observed concentration (Cmax)
To evaluate the PK (Cmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Time of maximum observed concentration (tmax)
To evaluate the PK (tmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Terminal rate constant (λz)
To evaluate the PK (λz) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Terminal elimination half-life (t½λz)
To evaluate the PK (t½λz) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)
To evaluate the PK (CL/F) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F)
To evaluate the PK (Vz/F) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Time of last measurable observed concentration (tlast)
To evaluate the PK (tlast) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
R AUC (Ratio of test treatment to reference based on AUC)
To evaluate the PK (R AUC) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
R Cmax (Ratio of test treatment to reference based on Cmax)
To evaluate the PK (R Cmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
F AUClast (Relative bioavailability based on AUClast)
To evaluate the PK (F AUClast) of different formulations of AZD5004 following single oral administration in healthy participants
From Day 1 to Day 22
Number of participants with adverse events (AEs), serious AEs and AESIs (adverse events of special interest)
To assess the safety and tolerability of different formulations of AZD5004 following single oral administration in healthy participants
Up to Follow up (3 to 7 days after discharge)
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja

  • Participants 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.

  • Female participants:

    1. of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy.
    2. of non-childbearing potential must be confirmed at the Screening Visit.

  • Male participants:

    1. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
    2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.

  • Have a Body Mass Index (BMI) of ≥ 23 kg/m2 but not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg.

  • History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  • Any clinically significant illness, medical/surgical procedure, or trauma
  • Participants who have a special dietary requirement and who are unable/unwilling to follow a uniform diet.
  • Participants positive for anti- hepatitis B core antibody (anti-HBc) or anti-hepatitis C Virus Antibody (anti-HCV).
  • Participants who are on or are planning to undertake a weight loss program during the study period.
  • Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit.
  • Positive screen for drugs of abuse, or alcohol or cotinine (nicotine).
  • Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
AstraZeneca logoAstraZeneca
Parexel logoParexel
Centraal Contactpersoon
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
2 Studielocaties in 1 landen

California

Research Site, Glendale, California, 91206, United States
Rekruterend

Maryland

Research Site, Baltimore, Maryland, 21225, United States
Nog niet rekruterend