T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
10 de septiembre de 2021 actualizado por: Corcept Therapeutics
A Randomized, Partial Double-Blind, Placebo- and Positive- Controlled, Multiple-Dose, 4-Way Crossover, Thorough QT/QTc (TQT) Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
This dedicated T/QT study will investigate the effect of relacorilant on cardiac repolarization in healthy participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This four-period crossover study with 12 treatment sequences includes relacorilant administered at therapeutic (400 mg once daily [QD]) and supra-therapeutic (800 mg QD) doses, placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control.
The positive control will serve to determine the sensitivity of the assay to detect small increases from baseline in the QTc interval.
Each of the four treatment periods will last 5 days with a washout of at least 10 days between periods.
Relacorilant and placebo to relacorilant will be administered double-blind; moxifloxacin will be administered open label.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Missouri
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Springfield, Missouri, Estados Unidos, 65802
- Single Site
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participant with a BMI ≥18.0 kg/m^2 and ≤30.0 kg/m^2 at screening
- No clinically significant abnormal findings with the physical examination, medical/surgical/medication history, vital signs, or clinical laboratory assessments and adequate cardiac conduction by electrocardiogram (ECG) without evidence of first-, second- or third-degree atrioventricular block
- Female participants of childbearing potential with a negative serum pregnancy test at screening and urine pregnancy test on Day -1 of Period 1
- All male participants agree to use condom to prevent exposure to partner; male participants with female partner of childbearing potential to use a second method of contraception
- Female participants of childbearing potential agree to use the highly effective contraception of low user dependency
- Participant is willing and able to comply with all study procedures and restrictions
- Participant understands the study procedures and agrees to participate by providing written informed consent.
Exclusion Criteria:
- Participant with history or presence of any clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, endocrine, immunologic, dermatologic, neurological, psychiatric disease or disorder or any uncontrolled medical illness which in the opinion of the investigator would jeopardize the safety of the participant, interfere with study assessments, or impact the validity of the study results
- Participant with a history or family history of additional risk factors for Torsade de Pointe (TdP)
- Participant with a marked prolongation of ECG intervals, including QTcF >450 milliseconds (msec), PR >200 msec, or QRS >120 msec
- Participant with resting heart rate of <45beats per minute (bpm) or >100 bpm
- Participant with clinically significant abnormal ECG results
- Participant who uses medications that could prolong the QT/QTc interval
- Participant taking medications/dietary supplements that are highly dependent on cytochrome (CYP)3A for clearance and cannot undergo dose modification upon co-administration with strong CYP3A inhibitors
- Participant using any strong CYP3A inhibitor/inducer or any other medications prohibited per protocol
- Participant who is receiving testosterone within 40 days prior to study start
- Participant with a positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
- Participant with a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19)
- Participant who has travelled abroad within 3 months prior to the screening visit or plans to travel abroad during the study
- Participant who has had a major surgery within the last 28 days prior to Screening
- Participant who received any investigational product within 30 days prior to Screening
- Participant who has a known or suspected allergy, or sensitivity to study products, or any of its ingredient(s), or to moxifloxacin
- Intolerance to repeated venipuncture or inability to swallow capsules
- Donation of blood within 56 days or plasma within 14 days prior to Screening or plans to donate during the entire study period
- Positive alcohol test and/or positive drugs of abuse screen or reports of a history of substance or alcohol abuse within 1 year prior to Screening
- Female participant who is pregnant, breastfeeding, or is planning to become pregnant during the entire study period
- Male participant with pregnant partner.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Treatment Sequence 1
Participants will receive relacorilant 400 mg once daily (QD) for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 2
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 3
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 4
Participants will receive relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 5
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 6
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 7
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 8
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 9
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 10
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 11
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Experimental: Treatment Sequence 12
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Otros nombres:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from Baseline in Cardiac QTcF
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Heart Rate (HR)
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in HR
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Cardiac PR Interval
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in Cardiac PR Interval
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Cardiac QRS Intervals
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in Cardiac QRS Intervals
Periodo de tiempo: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Number of Participants with a Categorical Outlier in QTcF
Periodo de tiempo: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Categorical Outlier in HR
Periodo de tiempo: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Categorical Outlier in PR Interval
Periodo de tiempo: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Categorical Outlier in QRS Intervals
Periodo de tiempo: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Treatment-emergent Change of T-wave Morphology
Periodo de tiempo: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Treatment-emergent Presence of U-waves
Periodo de tiempo: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Maximum Plasma Concentration (Cmax) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Periodo de tiempo: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Time to Reach Cmax (Tmax) of Plasma Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Periodo de tiempo: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Minimum Plasma Concentration (Cmin) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Periodo de tiempo: Before dosing on Day 5 of each treatment period
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Before dosing on Day 5 of each treatment period
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Area Under the Plasma-concentration Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Periodo de tiempo: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Area Under the Plasma-concentration Curve from Time Zero to 24 Hours Postdose (AUC0-24) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Periodo de tiempo: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Number of Participants with One or More Adverse Events
Periodo de tiempo: Up to Day 6 in each treatment period (up to 51 days)
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Up to Day 6 in each treatment period (up to 51 days)
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Number of Participants Discontinued From Study Treatment due to an Adverse Event
Periodo de tiempo: Up to Day 6 of each treatment period (up to 51 days)
|
Up to Day 6 of each treatment period (up to 51 days)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de enero de 2021
Finalización primaria (Actual)
17 de mayo de 2021
Finalización del estudio (Actual)
13 de julio de 2021
Fechas de registro del estudio
Enviado por primera vez
29 de enero de 2021
Primero enviado que cumplió con los criterios de control de calidad
11 de marzo de 2021
Publicado por primera vez (Actual)
12 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CORT125134-130
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .