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A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS

18 de mayo de 2020 actualizado por: Pfizer

A PHASE I, OPEN LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE STEADY STATE PHARMACOKINETIC DRUG-DRUG INTERACTION BETWEEN PF-06650833 AND PF-06651600 IN HEALTHY ADULT PARTICIPANTS

The purpose of this study is to evaluate the potential pharmacokinetic (PK) drug-drug interaction (DDI) between PF-06650833 and PF-06651600 in healthy adult participants.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

15

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

    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Pfizer New Haven 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 55 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD)
  • Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, temperature, 12-lead ECG, and laboratory tests.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
  • Infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
  • Participants with any of the protocol-listed acute or chronic infections or infection history.
  • History of febrile illness within 5 days prior to the first dose of investigational product (in both Periods).
  • History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
  • Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • Benign ethnic (cyclic) neutropenia.
  • Having received any live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  • Previous administration of an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of investigational product used in this study.
  • Known participation in a clinical trial of PF-06650833 or PF-06651600.
  • A positive urine drug test at screening or admission.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Participants with any of the protocol-listed abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary.
  • Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
  • Have a history of major organ transplant or hematopoietic stem cell/marrow transplant. Skin grafts are allowed.
  • Systemic therapy with any of the medications that are CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer) or CYP3A4 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of the trial medication.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle Considerations criteria of the protocol.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

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: Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PF-06650833 Cmax
Periodo de tiempo: Fold-change from Period 1/Day 5 to Period 2/Day 12
Maximum observed concentration (Cmax) derived from plasma
Fold-change from Period 1/Day 5 to Period 2/Day 12
PF-06650833 AUCtau
Periodo de tiempo: Fold-change from Period 1/Day 5 to Period 2/Day 12
Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
Fold-change from Period 1/Day 5 to Period 2/Day 12
PF-06651600 Cmax
Periodo de tiempo: Fold-change from Period 2/Day 7 to Period 2/Day 12
Maximum observed concentration (Cmax) derived from plasma
Fold-change from Period 2/Day 7 to Period 2/Day 12
PF-06651600 AUCtau
Periodo de tiempo: Fold-change from Period 2/Day 7 to Period 2/Day 12
Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
Fold-change from Period 2/Day 7 to Period 2/Day 12

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Percentage of participants with treatment emergent adverse events
Periodo de tiempo: From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
Percentage of participants with clinical laboratory test results above/below certain threshold
Periodo de tiempo: At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
Percentage of participants with vital signs above/below certain threshold
Periodo de tiempo: At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold
Periodo de tiempo: At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2

Colaboradores e Investigadores

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

Patrocinador

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 (Actual)

7 de febrero de 2019

Finalización primaria (Actual)

29 de abril de 2019

Finalización del estudio (Actual)

29 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

31 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

31 de enero de 2019

Publicado por primera vez (Actual)

1 de febrero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2020

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

18 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • B7921028

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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.

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. .

Ensayos clínicos sobre PF-06650833 alone

3
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