A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants
Healthy Participants
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - 55 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 48 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The study has 2 groups, one each focusing on co-administration of elecoglipron and atorvastatin or rosuvastatin to assess the pharmacokinetics (PK) of atorvastatin in healthy participants.
Leer la descripción completa
This is an open-label, fixed-sequence, conducted at 2 study centers with 2 groups.
Group 1 is designed to assess the PK of atorvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 6 treatment periods, and a follow-up visit. Each participant in Group 1 will be involved in the study for approximately 15 weeks.
Group 2 is designed to assess the PK of rosuvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 7 treatment periods, and a follow-up visit. Each participant in Group 2 will be involved in the study for approximately 16 weeks.
Group 1 and Group 2 are independent and non-sequential parts in this study. All parts of this study will be performed in healthy male and female participants
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- 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 throughout the study.
- Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion at screening visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
Exclusion Criteria:
- History of any clinically important disease or disorder.
- Participants with cardiovascular diseases, neuromuscular or neurogenic disease, type 1 or type 2 diabetes mellitus, or positive for human immunodeficiency virus (HIV), or uncontrolled thyroid disease.
- 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 within 4 weeks of the first administration of study intervention.
- Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to elecoglipron or paracetamol.
- Participants who have previously received elecoglipron within the last 6 months or was on statin treatment for ≤ 4 weeks prior to the study treatment.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Group 1: Period 1
Participants will receive a single dose of atorvastatin on Day 1.
Drug: Atorvastatin
Group 1: Period 2
Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.
Drug: Elecoglipron · Drug: Atorvastatin
Group 1: Period 3
Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.
Drug: Elecoglipron · Drug: Atorvastatin
Group 1: Period 4
Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 44. Participant will continue elecoglipron on Day 45. Participants will receive daily administration of different doses of elecoglipron alone from Day 46 to Day 58.
Drug: Elecoglipron · Drug: Atorvastatin
Group 1: Period 5
Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.
Drug: Elecoglipron · Drug: Atorvastatin
Group 1: Period 6
Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 62. Participant will continue elecoglipron alone from Day 63 to Day 64.
Drug: Elecoglipron · Drug: Atorvastatin
Group 2: Period 1
Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.
Drug: Elecoglipron · Drug: Rosuvastatin
Group 2: Period 2
Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 39. Participant will continue elecoglipron alone from Day 40 to Day 44.
Drug: Elecoglipron · Drug: Rosuvastatin
Group 2: Period 3
Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 45. Participant will continue on different doses of elecoglipron alone from Day 46 to Day 59.
Drug: Elecoglipron · Drug: Rosuvastatin
Group 2: Period 4
Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 60. Participant will continue elecoglipron alone from Day 61 to Day 65.
Drug: Elecoglipron · Drug: Rosuvastatin
Group 2: Period 5
Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 66. Participant will continue on elecoglipron alone from Day 67 to Day 69 and from Day 73 to Day 86.
Drug: Elecoglipron · Drug: Rosuvastatin
Group 2: Period 6
Participants will receive elecoglipron and a single dose of rosuvastatin in the morning on Day 87. Participants will continue elecoglipron from Day 87 to Day 91.
Drug: Elecoglipron · Drug: Rosuvastatin
Group 2: Period 7
Participants will receive a single dose of rosuvastatin in the morning on Day 106.
Drug: Rosuvastatin
Elecoglipron DRUG
Elecoglipron will be administered as oral tablet.
Atorvastatin DRUG
Atorvastatin will be administered as oral tablet.
Rosuvastatin DRUG
Rosuvastatin will be administered as oral tablet.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Maximum observed drug concentration (Cmax) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
AUCinf of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
AUClast of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
Cmax of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUClast (R AUClast) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on Cmax (R Cmax) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Terminal elimination half-life (t1/2λz) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Terminal rate constant (λz) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Time to reach maximum observed concentration (tmax) of atorvastatin
Plazo: Group 1: Day 1 to Day 71
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUCinf (R AUCinf) of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUClast (R AUClast) of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on Cmax (R Cmax) of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
t1/2λz of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
λz of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
tmax of rosuvastatin
Plazo: Group 2: Day 1 to Day 76
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
Medidas secundarias
Number of participants with adverse events (AEs) and adverse event of special interest (AESI)
Plazo: Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79
To examine the safety and tolerability of elecoglipron alone and in combination with atorvastatin (Group 1) or rosuvastatin (Group 2) in healthy participants.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
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2 centros
Research SiteGlendale, California, United StatesEstado desconocido
Research SiteBrooklyn, Maryland, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- AstraZeneca
- Inicio del estudio
- 16 abr 2026 Real
- Finalización primaria
- 25 ene 2027 Estimado
- Finalización del estudio
- 25 ene 2027 Estimado
- Primera publicación
- 16 abr 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026