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- Ensayo clínico NCT06562907
Estudio de GS-4571 en participantes sanos, participantes obesos no diabéticos y participantes no obesos con diabetes mellitus tipo 2 (DM2)
Un estudio de fase 1 para evaluar la farmacocinética, la seguridad y la tolerabilidad de dosis orales ascendentes únicas de GS-4571 en participantes sanos, dosis orales ascendentes múltiples de GS-4571 en participantes obesos no diabéticos y participantes no obesos con diabetes mellitus tipo 2 (DM2), y evaluar el efecto de los alimentos y un agente reductor de ácido sobre la farmacocinética de GS-4571
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM).
The primary objectives of this study are:
- To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571.
- To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571.
- To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gilead Clinical Study Information Center
- Número de teléfono: 1-833-445-3230 (GILEAD-0)
- Correo electrónico: GileadClinicalTrials@gilead.com
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33143
- Reclutamiento
- Qps-Mra, Llc.
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Texas
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San Antonio, Texas, Estados Unidos, 78232
- Reclutamiento
- ICON Early Phase Services, LLC
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Utah
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Salt Lake City, Utah, Estados Unidos, 84124
- Reclutamiento
- ICON
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- Age 18 through 55 years, for Parts A, B, and C, and 18 through 65 years, for Part D.
- Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.
- Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and < 30 kg/m^2, and no significant medical history.
Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.
- Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg/m^2 and < 45 kg/m^2 with a total body weight > 50 kg, and nondiabetic (HbA1c < 6.5%). Eligible individuals will also be individuals with stable body weight (< 5% change) for 90 days prior to screening visit based on individual report.
- Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and < 30 kg/m^2 and treated with diet and/or exercise, and/or metformin monotherapy.
Key Exclusion Criteria:
- Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol. This would include acute pancreatitis, or history of pancreatitis, acute gallbladder disease, and renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes [with the exception of T2DM for individuals included in Part D only]), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
- Current symptoms of diabetic retinopathy or examination indicating diabetic retinopathy within one year of screening.
- Any electrolyte disturbances identified at screening considered to be clinically significant in the opinion of the investigator (eg, hypokalemia, hypocalcemia, or hypomagnesemia).
- Any condition that could lead to electrolyte disturbances (eg, eating disorder) in the opinion of the investigator.
- History of syncope, palpitations, or unexplained dizziness.
- Active, or history of, significant cardiac disease or conduction abnormality
- History of implanted defibrillator or pacemaker.
- Have been treated with the following within 6 months prior to screening or is expected to receive these agents during the study: GLP-1RAs, systemic steroids, immunosuppressant therapies, or chemotherapeutic agents (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
- Previously stopped use of GLP-1RAs secondary to severe side effects including nausea, constipation, diarrhea, or emesis.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Part A Single-ascending Dose (SAD) in Healthy Participants
Participants will be randomized into 4 + (optional) 1 dose escalating cohorts and will receive GS-4571 or placebo to match (PTM) GS-4571 on Day 1, to determine the maximum tolerated dose:
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Administered orally Administered orally |
|
Experimental: Part B Food/PPI Effect in Healthy Participants
Participants will be randomized into 2 sequence groups in Cohort 6 and will receive the highest dose found to be safe and well tolerated in Part A of GS-4571 and omeprazole. The two sequential groups will receive the following treatments:
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Administered orally Administered orally |
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Experimental: Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese Participants
Participants randomized in Cohorts 7-9 will be randomized to receive up to 4 escalating doses of GS-4571 or PTM QD for 12 weeks, as follows:
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Administered orally Administered orally |
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Experimental: Part D Multiple Dose in Nonobese Participants With T2DM
Participants randomized in Cohort 11 will receive up to the highest dose of GS-4571 or PTM in T2DM, QD, in a non-fasting state for 12 weeks. |
Administered orally Administered orally |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Porcentaje de participantes en eventos adversos surgidos del tratamiento (EAET), eventos adversos graves (AAG) o muertes
Periodo de tiempo: Día 1 hasta 95 días
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Día 1 hasta 95 días
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Porcentaje de participantes con anomalías de laboratorio surgidas del tratamiento
Periodo de tiempo: Día 1 hasta 95 días
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Día 1 hasta 95 días
|
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Single-Dose PK Parameter AUCinf of GS-4571
Periodo de tiempo: Up to 96 hours postdose
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AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time. |
Up to 96 hours postdose
|
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Single-Dose PK Parameter Cmax of GS-4571
Periodo de tiempo: Up to 96 hours postdose
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Cmax is defined as the maximum observed concentration of drug in plasma. |
Up to 96 hours postdose
|
|
Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571
Periodo de tiempo: Up to 96 hours postdose
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AUCtau is defined as area under the concentration versus time curve over the dosing interval. |
Up to 96 hours postdose
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Multiple-Dose Plasma PK Parameter: Cmax of GS-4571
Periodo de tiempo: Up to 96 hours postdose
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Cmax is defined as the maximum observed concentration of drug in plasma. |
Up to 96 hours postdose
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Cambio porcentual desde el inicio (CFB) en el peso corporal en participantes obesos no diabéticos
Periodo de tiempo: Día 1 hasta 95 días
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Día 1 hasta 95 días
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Gilead Study Director, Gilead Sciences
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GS-US-506-6610
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .