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A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886821
First Posted: April 23, 2009
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
April 22, 2009
April 23, 2009
March 2, 2017
April 18, 2017
April 18, 2017
October 2008
June 2011   (Final data collection date for primary outcome measure)
  • Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 ]
    AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1 [ Time Frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1 ]
  • Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 ]
  • Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22 [ Time Frame: pre-dose, 1 and 6 hours post-dose on Day 22 ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1 [ Time Frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1 ]
  • Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 ]
  • Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22 [ Time Frame: pre-dose, 1 and 6 hours post-dose on Day 22 ]
To evaluate the safety and tolerability of single, escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM [ Time Frame: Throughout duration of study ]
Complete list of historical versions of study NCT00886821 on ClinicalTrials.gov Archive Site
  • Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 ]
    Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
  • Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 ]
    Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
  • Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22 [ Time Frame: pre-dose, 1 and 6 hours post-dose on Day 22 ]
    Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
  • Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 ]
    MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.
  • Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 ]
    Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1 [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 ]
    AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).
  • To characterize the pharmacokinetics of CVX-096 in serum after administration, under fasting conditions, of single, escalating, subcutaneous doses of CVX-096 to adult subjects with T2DM [ Time Frame: Throughout duration of study ]
  • To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM [ Time Frame: Days 0, 3, 7 ]
  • To evaluate the effect on mean plasma glucose (MPG) of a single dose of CVX-096 [ Time Frame: Days 0, 3, 7 ]
  • To assess single dose immunogenicity [ Time Frame: Throughout duration of study ]
  • Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: 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 that were absent before treatment or that worsened relative to pretreatment state.
  • Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7 [ Time Frame: Baseline, Day 3 and 7 ]
    Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.
  • Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7 [ Time Frame: Baseline, Day 3 and 7 ]
    It was assessed by 7-point glucose measurements via the glucose oxidase method.
  • Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]
    Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).
  • Number of Participants With Clinically Significant Vital Signs [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]
    Criteria for vital signs: pulse rate <40 beats per minute (bpm), supine, sitting and erect pulse rate <40 bpm, supine pulse rate >120 bpm, sitting pulse rate >120 bpm, and erect pulse rate >120 bpm; systolic blood pressure: SBP <90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (>=) 30 mmHg; diastolic blood pressure: DBP <50 mmHg, change from baseline in DBP >=20 mmHg.
  • Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]
    Criteria for ECG findings: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >=100 msec, and >=50 percent increase when baseline <=100 msec; QT/QTc interval (corrected QT interval) >=500 msec.
  • Number of Participants With Clinically Significant Physical Examinations [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]
    Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.
  • Stage 1: Number of Participants With Hypoglycemia [ Time Frame: Day 1: 0 hour (pre-dose) up to 48 hours post dose ]
    Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level <60 mg/dL if accompanied by symptoms, blood glucose level <=50 mg/dL regardless of symptoms.
  • Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms [ Time Frame: Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10 ]
    Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate <35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting >30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting >30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of >30 seconds duration; asymptomatic frequent premature ventricular complexes (=>200/24 hours); asymptomatic frequent premature atrial complexes (=>240/24 hours).
  • Stage 1: Number of Participants With Anti-Drug Antibodies [ Time Frame: Day 0, 8, 14, 15, 21, 28 and 35 ]
  • Stage 2: Number of Participants With Anti-Drug Antibodies [ Time Frame: Day 0, 29 and 50 ]
Not Provided
 
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects
The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
Experimental: 1
Intervention: Biological: CVX-096
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
  • Hb A1c between 7-10%.
  • Fasting C-peptide >0.4 nmol/L.

Exclusion Criteria:

  • History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
  • Patients with pancreatitis or considered a high risk for pancreatitis.
  • History of contraindications to metformin therapy.
  • Previous treatment with an approved or investigational GLP 1 mimetic.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00886821
B1111001
CVX-096-101 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP