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| ID | Type | Description | Link |
|---|---|---|---|
| CVX-096-101 | Other Identifier | Alias Study Number |
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The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVX-096 | Biological | Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 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. | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1 | 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 | 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 | pre-dose, 1 and 6 hours post-dose on Day 22 | |
| Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1 | 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 | 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 | pre-dose, 1 and 6 hours post-dose on Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 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. | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Miami Gardens | Florida | 33169 | United States | ||
| Cetero Research - San Antonio |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Study consist of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: PF-04856883 0.1 Milligram (mg) | Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. |
| FG001 | Cohort 2: PF-04856883 0.3 mg | Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. |
| FG002 | Cohort 3: PF-04856883 1.0 mg | Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. |
| FG003 | Cohort 4: PF-04856883 3.0 mg | Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. |
| FG004 | Cohort 5: PF-04856883 6.0 mg | Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. |
| FG005 | Cohort 6: PF-04856883 12.0 mg | Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. |
| FG006 | Cohort 7: PF-04856883 24.0 mg | Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. |
| FG007 | Cohort 8: PF-04856883 36.0 mg | Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. |
| FG008 | Cohort 9: PF-04856883 18.0 mg | Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. |
| FG009 | Cohort 1-9: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. |
| FG010 | Cohort 10: PF-04856883 15.0 mg | Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. |
| FG011 | Cohort 11: PF-04856883 20.0 mg | Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. |
| FG012 | Cohort 12: PF-04856883 25.0 mg | Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. |
| FG013 | Cohort 10-12: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
| |||||||||||||
| Stage 2 |
|
Safety population included all randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: PF-04856883 0.1 Milligram (mg) | Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. |
| BG001 | Cohort 2: PF-04856883 0.3 mg | Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 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. | Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr)/mL | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: PF-04856883 0.1 Milligram (mg) | Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 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. |
| pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 |
| Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 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. | pre-dose, 1 and 6 hours post-dose on Day 22 |
| Stage 1: Mean Residence Time (MRT) of PF-04856883 on 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. | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 |
| Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on 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. | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 |
| Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on 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). | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 |
| Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50 |
| Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at 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. | Baseline, Day 3 and 7 |
| Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7 | It was assessed by 7-point glucose measurements via the glucose oxidase method. | Baseline, Day 3 and 7 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | 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). | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
| Number of Participants With Clinically Significant Vital Signs | 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. | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 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. | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
| Number of Participants With Clinically Significant Physical Examinations | 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. | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
| Stage 1: Number of Participants With Hypoglycemia | 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. | Day 1: 0 hour (pre-dose) up to 48 hours post dose |
| Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms | 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). | Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10 |
| Stage 1: Number of Participants With Anti-Drug Antibodies | Day 0, 8, 14, 15, 21, 28 and 35 |
| Stage 2: Number of Participants With Anti-Drug Antibodies | Day 0, 29 and 50 |
| San Antonio |
| Texas |
| 78229 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Cohort 3: PF-04856883 1.0 mg | Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. |
| BG003 | Cohort 4: PF-04856883 3.0 mg | Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. |
| BG004 | Cohort 5: PF-04856883 6.0 mg | Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. |
| BG005 | Cohort 6: PF-04856883 12.0 mg | Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. |
| BG006 | Cohort 7: PF-04856883 24.0 mg | Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. |
| BG007 | Cohort 8: PF-04856883 36.0 mg | Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. |
| BG008 | Cohort 9: PF-04856883 18.0 mg | Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. |
| BG009 | Cohort 9: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively. |
| BG010 | Cohort 10: PF-04856883 15.0 mg | Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. |
| BG011 | Cohort 11: PF-04856883 20.0 mg | Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. |
| BG012 | Cohort 12: PF-04856883 25.0 mg | Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. |
| BG013 | Cohort 10-12: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22. |
| BG014 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
| OG001 | Cohort 2: PF-04856883 0.3 mg | Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. |
| OG002 | Cohort 3: PF-04856883 1.0 mg | Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. |
| OG003 | Cohort 4: PF-04856883 3.0 mg | Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. |
| OG004 | Cohort 5: PF-04856883 6.0 mg | Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. |
| OG005 | Cohort 6: PF-04856883 12.0 mg | Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. |
| OG006 | Cohort 7: PF-04856883 24.0 mg | Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. |
| OG007 | Cohort 8: PF-04856883 36.0 mg | Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. |
|
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| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1 | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | hour | 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 |
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| Primary | Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8 | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts. | Posted | Median | Full Range | hour | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 |
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| Primary | Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22 | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | hour | pre-dose, 1 and 6 hours post-dose on Day 22 |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1 | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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 |
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| Primary | Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8 | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 |
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| Primary | Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22 | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1 and 6 hours post-dose on Day 22 |
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| Secondary | Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 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. | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol. | Posted | Mean | Standard Deviation | hour | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 |
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| Secondary | Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 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. | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts. | Posted | Mean | Standard Deviation | hour | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 |
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| Secondary | Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 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. | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hour | pre-dose, 1 and 6 hours post-dose on Day 22 |
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| Secondary | Stage 1: Mean Residence Time (MRT) of PF-04856883 on 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. | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol. | Posted | Median | Full Range | hour | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 |
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| Secondary | Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on 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. | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/hr) | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 |
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| Secondary | Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on 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). | PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 |
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| Other Pre-specified | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50 |
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| Other Pre-specified | Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at 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. | Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | milligram*hour per deciliter (mg*hr)/dL | Baseline, Day 3 and 7 |
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| Other Pre-specified | Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7 | It was assessed by 7-point glucose measurements via the glucose oxidase method. | Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. | Posted | Mean | Standard Deviation | milligram per deciliter(mg/dL) | Baseline, Day 3 and 7 |
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| Other Pre-specified | Number of Participants With Clinically Significant Laboratory Abnormalities | 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). | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
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| Other Pre-specified | Number of Participants With Clinically Significant Vital Signs | 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. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
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| Other Pre-specified | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 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. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
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| Other Pre-specified | Number of Participants With Clinically Significant Physical Examinations | 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. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 |
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| Other Pre-specified | Stage 1: Number of Participants With Hypoglycemia | 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. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Day 1: 0 hour (pre-dose) up to 48 hours post dose |
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| Other Pre-specified | Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms | 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). | Safety population will consist of all randomized patients who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10 |
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| Other Pre-specified | Stage 1: Number of Participants With Anti-Drug Antibodies | Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Count of Participants | Participants | Day 0, 8, 14, 15, 21, 28 and 35 |
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| Other Pre-specified | Stage 2: Number of Participants With Anti-Drug Antibodies | Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Count of Participants | Participants | Day 0, 29 and 50 |
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|
|
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Cohort 2: PF-04856883 0.3 mg | Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. | 0 | 6 | 2 | 6 |
| EG002 | Cohort 3: PF-04856883 1.0 mg | Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. | 0 | 6 | 5 | 6 |
| EG003 | Cohort 4: PF-04856883 3.0 mg | Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. | 0 | 7 | 1 | 7 |
| EG004 | Cohort 5: PF-04856883 6.0 mg | Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. | 0 | 6 | 2 | 6 |
| EG005 | Cohort 6: PF-04856883 12.0 mg | Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. | 0 | 6 | 4 | 6 |
| EG006 | Cohort 7: PF-04856883 24.0 mg | Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. | 0 | 6 | 5 | 6 |
| EG007 | Cohort 8: PF-04856883 36.0 mg | Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. | 0 | 6 | 6 | 6 |
| EG008 | Cohort 9: PF-04856883 18.0 mg | Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. | 0 | 6 | 3 | 6 |
| EG009 | Cohort 1-9: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. | 0 | 18 | 4 | 18 |
| EG010 | Cohort 10: PF-04856883 15.0 mg | Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. | 0 | 9 | 5 | 9 |
| EG011 | Cohort 11: PF-04856883 20.0 mg | Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. | 0 | 9 | 7 | 9 |
| EG012 | Cohort 12: PF-04856883 25.0 mg | Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. | 0 | 13 | 8 | 13 |
| EG013 | Cohort 10-12: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22. | 0 | 9 | 4 | 9 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Hematochezia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Application site rash | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Injection site rash | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Swelling | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Milia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Tinea infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D004700 | Endocrine System Diseases |
| SAEs |
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| Change at Day 7 |
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| Change at Day 7 |
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| Day 8 |
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| Day 14 |
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| Day 15 |
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| Day 21 |
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| Day 28 |
|
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| Day 35 |
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| Day 29 (n= 9, 8, 7, 8) |
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| Day 50 (n= 9, 8, 8, 8) |
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