Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
28. července 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
84
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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Chula Vista, California, Spojené státy, 91911
- Profil Institute for Clinical Research, Inc.
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Florida
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Miami, Florida, Spojené státy, 33169
- Elite Research Institute
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Miramar, Florida, Spojené státy, 33025
- Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
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Georgia
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Atlanta, Georgia, Spojené státy, 30308
- Atlanta Center for Medical Research
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Nebraska
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Omaha, Nebraska, Spojené státy, 68154
- ICON Clinical Pharmacology, LLC
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19139
- CRI Worldwide, LLC
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Texas
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San Antonio, Texas, Spojené státy, 78209
- Healthcare Discoveries LLC d/b/a ICON Development Solutions
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: Treatment Arm 1 (Stage 1A)
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Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Ostatní jména:
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Experimentální: Treatment Arm 2 (Stage 1A)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
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Experimentální: Treatment Arm 3 (Stage 1A)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
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Experimentální: Treatment Arm 4 (Stage 1A)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
|
Komparátor placeba: Treatment Arm 5 (Stage 1B)
|
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Ostatní jména:
|
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Experimentální: Treatment Arm 6 (Stage 1B)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
|
Experimentální: Treatment Arm 7 (Stage 1B)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
|
Experimentální: Treatment Arm 8 (Stage 1B)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
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Komparátor placeba: Treatment Arm 9 (Stage 2)
|
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Ostatní jména:
|
|
Experimentální: Treatment Arm 10 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
|
Experimentální: Treatment Arm 11 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
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Experimentální: Treatment Arm 12 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
|
Experimentální: Treatment Arm 13 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Ostatní jména:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Časové okno: 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
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: Baseline, Day 8, 15 and 29
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 1, 29 and 50
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Day 1, 29 and 50
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. března 2011
Primární dokončení (Aktuální)
1. prosince 2011
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
9. února 2011
První předloženo, které splnilo kritéria kontroly kvality
21. února 2011
První zveřejněno (Odhad)
23. února 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. února 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. července 2017
Naposledy ověřeno
1. července 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- B1111002
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .