Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
28 de julio de 2017 actualizado por: Pfizer
A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
84
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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California
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Chula Vista, California, Estados Unidos, 91911
- Profil Institute for Clinical Research, Inc.
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Florida
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Miami, Florida, Estados Unidos, 33169
- Elite Research Institute
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Miramar, Florida, Estados Unidos, 33025
- Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Atlanta Center for Medical Research
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68154
- ICON Clinical Pharmacology, LLC
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19139
- CRI Worldwide, LLC
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Texas
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San Antonio, Texas, Estados Unidos, 78209
- Healthcare Discoveries LLC d/b/a ICON Development Solutions
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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 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- History of Type 2 diabetes and currently being treated with high dose metformin
- BMI between 22.0 and 40.0 kg/m2
- HbA1c between 7.0-10.0%
- Fasting C-peptide >1.21 ng/mL
Exclusion Criteria:
- History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
- Treatment with anti-diabetic therapies other than metformin
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
- Males or women of childbearing potential
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Treatment Arm 1 (Stage 1A)
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Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 2 (Stage 1A)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 3 (Stage 1A)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 4 (Stage 1A)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Comparador de placebos: Treatment Arm 5 (Stage 1B)
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Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 6 (Stage 1B)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 7 (Stage 1B)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 8 (Stage 1B)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Comparador de placebos: Treatment Arm 9 (Stage 2)
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Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 10 (Stage 2)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 11 (Stage 2)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 12 (Stage 2)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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Experimental: Treatment Arm 13 (Stage 2)
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Single subcutaneous injection of PF-04856883
Otros nombres:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Periodo de tiempo: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Number of Participants With Clinically Significant Physical Examination Findings
Periodo de tiempo: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Periodo de tiempo: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF).
ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec.
The number of participants with potentially clinically significant ECG findings at any visit were reported.
IFB = increase from baseline.
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Number of Participants With Vital Sign Abnormalities
Periodo de tiempo: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
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Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
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Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
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Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Periodo de tiempo: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2*
ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR.
Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
It is obtained from AUC (0 - t) plus AUC (t - ∞).
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22
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Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22
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Apparent Clearance (CL/F) of PF-04856883: Stage 1
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Outcome measure was planned to be analyzed in Stage 1 only.
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Apparent Clearance (CL/F) of PF-04856883: Stage 2
Periodo de tiempo: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Outcome measure was planned to be analyzed in Stage 2 only.
Data was not estimable if values were below the limit of quantification.
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predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Periodo de tiempo: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Periodo de tiempo: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Periodo de tiempo: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Periodo de tiempo: Baseline, Day 3 and 8
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Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC
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Baseline, Day 3 and 8
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Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Periodo de tiempo: Baseline, Day 3, 15, 24, 29 and 50
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Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
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Baseline, Day 3, 15, 24, 29 and 50
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Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Periodo de tiempo: Baseline, Day 3 and 8
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Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
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Baseline, Day 3 and 8
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Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Periodo de tiempo: Baseline, Day 3, 15, 24, 29 and 50
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Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
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Baseline, Day 3, 15, 24, 29 and 50
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Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Periodo de tiempo: Baseline, Day 3 and 8
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Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
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Baseline, Day 3 and 8
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Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Periodo de tiempo: Baseline, Day 3, 15, 24, 29 and 50
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Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
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Baseline, Day 3, 15, 24, 29 and 50
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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Periodo de tiempo: Baseline, Day 2, 4, 6, 15, 22 and 29
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Baseline, Day 2, 4, 6, 15, 22 and 29
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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Periodo de tiempo: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
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Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
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Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Periodo de tiempo: Baseline, Day 30
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A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
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Baseline, Day 30
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Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Periodo de tiempo: Baseline, Day 29 and 50
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HbA1c is a measure of the glycosylated hemoglobin.
Change (measured as percent): HbA1c at observation minus HbA1c at baseline.
Outcome measure was planned to analyzed only for Stage 2.
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Baseline, Day 29 and 50
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Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Periodo de tiempo: Baseline, Day 8, 15 and 29
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Baseline, Day 8, 15 and 29
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Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Periodo de tiempo: Baseline, Day 8, 15, 22, 29 and 50
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Baseline, Day 8, 15, 22, 29 and 50
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Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Periodo de tiempo: Baseline, Day 8, 15 and 29
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Baseline, Day 8, 15 and 29
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Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Periodo de tiempo: Baseline, Day 8, 15, 22, 29 and 50
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Baseline, Day 8, 15, 22, 29 and 50
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Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Periodo de tiempo: Day 1 and 29
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Day 1 and 29
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Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Periodo de tiempo: Day 1, 29 and 50
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Day 1, 29 and 50
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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)
1 de marzo de 2011
Finalización primaria (Actual)
1 de diciembre de 2011
Finalización del estudio (Actual)
1 de abril de 2012
Fechas de registro del estudio
Enviado por primera vez
9 de febrero de 2011
Primero enviado que cumplió con los criterios de control de calidad
21 de febrero de 2011
Publicado por primera vez (Estimar)
23 de febrero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
28 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B1111002
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. .