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L'essai clinique NCT07455825 pour Participants en bonne santé est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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AstraZenecaA Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years Phase I 64
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L'essai clinique NCT07455825 est conçu pour étudier le traitement de Participants en bonne santé. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : en recrutement. L'étude a débuté le 5 mars 2026 et vise à recruter 64 participants. Dirigée par AstraZeneca, l'étude devrait être terminée d'ici le 1 juin 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 mars 2026.
Résumé succinct
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.
Description détaillée
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...
Afficher plusTitre officiel
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
Pathologies
Participants en bonne santéAutres identifiants de l'étude
- D7260C00008
Numéro NCT
Date de début (réel)
2026-03-05
Dernière mise à jour publiée
2026-03-12
Date de fin (estimée)
2026-06-01
Inscription (estimée)
64
Type d'étude
Interventionnel
PHASE
Phase I
Statut
En recrutement
Mots clés
Glucagon-like peptide-1 receptor agonist
Anti-hyperglycemic
Pharmacokinetics (PK)
Oral formulations
Formulation bridging
Weight management
Type 2 Diabetes Mellitus
Anti-hyperglycemic
Pharmacokinetics (PK)
Oral formulations
Formulation bridging
Weight management
Type 2 Diabetes Mellitus
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Étude croisée
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalCohort 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. |
ExpérimentalCohort 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. |
ExpérimentalCohort 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. |
ExpérimentalCohort 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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) |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
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:
- 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.
- of non-childbearing potential must be confirmed at the Screening Visit.
Male participants:
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- 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.
AstraZenecaParexelContact central de l'étude
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
2 Centres de l'étude dans 1 pays
California
Research Site, Glendale, California, 91206, United States
En recrutement
Maryland
Research Site, Baltimore, Maryland, 21225, United States
Pas encore en recrutement