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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 Fase I 64
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07455825 procura avaliar tratamento para Participantes saudáveis. Este é um estudo intervencionista de Fase I. Seu status atual é: em recrutamento. O estudo começou em 5 de março de 2026 e pretende incluir 64 participantes. Coordenado por AstraZeneca e deve ser concluído em 1 de junho de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 12 de março de 2026.
Resumo
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.
Descrição detalhada
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...
Mostrar maisTítulo oficial
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
Condições médicas
Participantes saudáveisOutros IDs do estudo
- D7260C00008
Número NCT
Data de início (real)
2026-03-05
Última atualização postada
2026-03-12
Data de conclusão (estimada)
2026-06-01
Inscrição (estimada)
64
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Em recrutamento
Palavras-chave
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
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalCohort 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. |
ExperimentalCohort 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. |
ExperimentalCohort 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. |
ExperimentalCohort 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
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.
AstraZenecaParexelContato central do estudo
Contato: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
2 Locais do estudo em 1 países
California
Research Site, Glendale, California, 91206, United States
Em recrutamento
Maryland
Research Site, Baltimore, Maryland, 21225, United States
Ainda não recrutando