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Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

2017. július 28. frissítette: 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.

A tanulmány áttekintése

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

84

Fázis

  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • California
      • Chula Vista, California, Egyesült Államok, 91911
        • Profil Institute for Clinical Research, Inc.
    • Florida
      • Miami, Florida, Egyesült Államok, 33169
        • Elite Research Institute
      • Miramar, Florida, Egyesült Államok, 33025
        • Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
    • Georgia
      • Atlanta, Georgia, Egyesült Államok, 30308
        • Atlanta Center for Medical Research
    • Nebraska
      • Omaha, Nebraska, Egyesült Államok, 68154
        • ICON Clinical Pharmacology, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, Egyesült Államok, 19139
        • CRI Worldwide, LLC
    • Texas
      • San Antonio, Texas, Egyesült Államok, 78209
        • Healthcare Discoveries LLC d/b/a ICON Development Solutions

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Női

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Placebo Comparator: Treatment Arm 1 (Stage 1A)
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 2 (Stage 1A)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 3 (Stage 1A)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 4 (Stage 1A)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Placebo Comparator: Treatment Arm 5 (Stage 1B)
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 6 (Stage 1B)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 7 (Stage 1B)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 8 (Stage 1B)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Placebo Comparator: Treatment Arm 9 (Stage 2)
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 10 (Stage 2)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 11 (Stage 2)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 12 (Stage 2)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096
Kísérleti: Treatment Arm 13 (Stage 2)
Single subcutaneous injection of PF-04856883
Más nevek:
  • CVX-096
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Más nevek:
  • CVX-096

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Időkeret: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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.
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Number of Participants With Clinically Significant Physical Examination Findings
Időkeret: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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.
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Időkeret: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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.
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Number of Participants With Vital Sign Abnormalities
Időkeret: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
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.
Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Időkeret: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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).
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Időkeret: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Időkeret: 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
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
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Időkeret: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Időkeret: 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
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
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
Időkeret: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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 - ∞).
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Időkeret: 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
Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
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
Apparent Clearance (CL/F) of PF-04856883: Stage 1
Időkeret: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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.
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Apparent Clearance (CL/F) of PF-04856883: Stage 2
Időkeret: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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.
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Időkeret: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Időkeret: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Időkeret: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Időkeret: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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
Időkeret: Baseline, Day 3 and 8
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
Baseline, Day 3 and 8
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
Időkeret: Baseline, Day 3, 15, 24, 29 and 50
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.
Baseline, Day 3, 15, 24, 29 and 50
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Időkeret: Baseline, Day 3 and 8
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.
Baseline, Day 3 and 8
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
Időkeret: Baseline, Day 3, 15, 24, 29 and 50
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.
Baseline, Day 3, 15, 24, 29 and 50
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Időkeret: Baseline, Day 3 and 8
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.
Baseline, Day 3 and 8
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
Időkeret: Baseline, Day 3, 15, 24, 29 and 50
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.
Baseline, Day 3, 15, 24, 29 and 50
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Időkeret: Baseline, Day 2, 4, 6, 15, 22 and 29
Baseline, Day 2, 4, 6, 15, 22 and 29
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Időkeret: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Időkeret: Baseline, Day 30
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.
Baseline, Day 30
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Időkeret: Baseline, Day 29 and 50
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.
Baseline, Day 29 and 50
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Időkeret: Baseline, Day 8, 15 and 29
Baseline, Day 8, 15 and 29
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Időkeret: Baseline, Day 8, 15, 22, 29 and 50
Baseline, Day 8, 15, 22, 29 and 50
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Időkeret: Baseline, Day 8, 15 and 29
Baseline, Day 8, 15 and 29
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Időkeret: Baseline, Day 8, 15, 22, 29 and 50
Baseline, Day 8, 15, 22, 29 and 50
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Időkeret: Day 1 and 29
Day 1 and 29
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Időkeret: Day 1, 29 and 50
Day 1, 29 and 50

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2011. március 1.

Elsődleges befejezés (Tényleges)

2011. december 1.

A tanulmány befejezése (Tényleges)

2012. április 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2011. február 9.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2011. február 21.

Első közzététel (Becslés)

2011. február 23.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. február 9.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. július 28.

Utolsó ellenőrzés

2017. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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