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A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose

30 de abril de 2019 actualizado por: Mirum Pharmaceuticals, Inc.

A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects

The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.

Descripción general del estudio

Estado

Terminado

Tipo de estudio

Intervencionista

Inscripción (Actual)

8

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

    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53704
        • Covance Madison Clinical Research Unit

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 50 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  1. Age between 18 and 50 years, inclusive, at the time of consent.
  2. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
  3. Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
  4. Ability to swallow all investigational product.
  5. A minimum of 1 bowel movement per day.

Exclusion Criteria:

  1. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
  2. Current or relevant history of physical or psychiatric illness.
  3. Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
  4. Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
  5. Known history of alcohol or other substance abuse within the last year.
  6. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
  7. Within 30 days prior to the dose of investigational product:

    • Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
    • Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
    • Have had any substantial changes in eating habits, as assessed by the investigator.
  8. Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
  9. Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
  10. A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
  11. Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
  12. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
  13. Use of tobacco in any form
  14. Routine consumption of more than 2 units of caffeine per day
  15. Current use of any medication including over-the-counter, herbal, or homeopathic preparations
  16. An inability to follow a standardized diet and meal schedule or inability to fast
  17. Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
  18. Exposure to clinically significant radiation within 12 months prior to the dose of investigational product

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: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental Drug
single oral dose radiolabelled 50mg of SHP626
single oral dose 50mg SHP626 with approximately 5.95 μCi RAD

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
Periodo de tiempo: Day 1 to day 10
Day 1 to day 10
Total radioactivity (RAD) in whole blood and plasma
Periodo de tiempo: Day 1 to day 10
Day 1 to day 10
To determine the total RAD in urine and feces.
Periodo de tiempo: Day 1 to day 10
Day 1 to day 10
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
Periodo de tiempo: Day 1 to day 10
Day 1 to day 10
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
Periodo de tiempo: Day 1 to Day 10
Day 1 to Day 10
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
Periodo de tiempo: Day 1 to Day 10
Day 1 to Day 10
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
Periodo de tiempo: Day 1 to Day 10
Day 1 to Day 10
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
Periodo de tiempo: Day 1-10
Day 1-10
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
Periodo de tiempo: Day 1-10
Day 1-10
Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
Periodo de tiempo: Day 1-10
Day 1-10
Excreted Percent of RAD recovered in stool over the dosing interval
Periodo de tiempo: Day 1-10
Day 1-10
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
Periodo de tiempo: Day 1-10
Day 1-10
Excreted Percent of RAD recovered in urine over the dosing interval
Periodo de tiempo: Day 1-10
Day 1-10
Renal Clearance (CLR ) of 50mg [14C]-SHP626
Periodo de tiempo: Day 1 -10
Day 1 -10

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification
Periodo de tiempo: Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification
Periodo de tiempo: Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting
Periodo de tiempo: Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings
Periodo de tiempo: Screening to day 7
AEs will be coded using the agreed upon version of MedDRA. The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term. TEAEs will be further summarized by severity and relationship to investigational product. AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.
Screening to day 7
Changes from baseline in vital signs
Periodo de tiempo: Screening to day 7
Screening to day 7
Changes from baseline in ECGs
Periodo de tiempo: Screening to day 7
Screening to day 7
Changes from baseline in hematology
Periodo de tiempo: Screening to day 7
Screening to day 7
Changes from baseline in coagulation
Periodo de tiempo: Screening to day 7
Screening to day 7
Changes in baseline in urinalysis
Periodo de tiempo: Screening to day 7
Screening to day 7
Changes in baseline in chemistry
Periodo de tiempo: Screening to day 7
Screening to day 7

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Nicholas Siebers, MD, Covance Clinical Pharmacology

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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

1 de octubre de 2015

Finalización primaria (Actual)

1 de octubre de 2015

Finalización del estudio (Actual)

1 de octubre de 2015

Fechas de registro del estudio

Enviado por primera vez

30 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

6 de octubre de 2015

Publicado por primera vez (Estimar)

8 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

30 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • SHP626-102

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. .

Ensayos clínicos sobre Esteatohepatitis no alcohólica

Ensayos clínicos sobre SHP626

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