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The study was terminated on December 19th, 2013 due to a business decision by the Sponsor. No safety concerns have been observed in this study.
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This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 100 mg PF-05231023 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period. | Day -7 through the last follow-up (Day 68) |
| Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern | Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm. | Days -7 up to the last follow-up (Day 68) |
| Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern | ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times. | Days -7 up to the last follow-up (Day 68) |
| Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies. | Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Clinical Laboratory Measurements | The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. | Days -7 up to the last follow-up (Day 68) |
| Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Orlando | Florida | 32803 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25. |
| FG001 | PF-05231023 100 mg | PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study medication (PF-05231023 or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25. |
| BG001 | PF-05231023 100 mg | PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period. | All participants who received at least 1 dose of study medication (PF-05231023 or placebo). | Posted | Number | Participants | Day -7 through the last follow-up (Day 68) |
|
Day -7 through Day 68 (AEs occurred after first dose of study drug were treatment-emergent). Serious AEs (SAEs) were reported from time that subject provided informed consent until 28 calendar days after last dose of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Placebo | Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
Not provided
| 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 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000604284 | PF-05231023 |
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| 100 mg PF-05231023 | Drug | 100 mg IV infusion twice a week for 4 weeks |
|
| Days 1 up to the last follow-up (Day 68) |
| Days 1 and 25 |
| Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Days 1 and 25 |
| Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Day 25 |
| Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Day 25 |
| Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Day 25 |
| Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Day 25 |
| Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Day 25 |
| Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Day 25 |
| Orlando |
| Florida |
| 32804 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern | Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm. | All participants who received at least 1 dose of study medication (PF-05231023 or placebo). | Posted | Number | Participants | Days -7 up to the last follow-up (Day 68) |
|
|
|
| Primary | Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern | ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times. | All participants who received at least 1 dose of study medication (PF-05231023 or placebo). | Posted | Number | Participants | Days -7 up to the last follow-up (Day 68) |
|
|
|
| Secondary | Number of Participants With Abnormal Clinical Laboratory Measurements | The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. | All participants who received at least 1 dose of study medication (PF-05231023 or placebo). | Posted | Number | Participants | Days -7 up to the last follow-up (Day 68) |
|
|
|
| Primary | Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies. | Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing. | All participants who received at least 1 dose of active study medication (PF-05231023). Neutralizing antibodies were not tested because all participants who received PF-05231023 100 mg tested negative for anti-PF-05231023 antibodies. | Posted | Number | Participants | Days 1 up to the last follow-up (Day 68) |
|
|
|
| Secondary | Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | AUCtau for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study. | Posted | Days 1 and 25 |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Cmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study. | Posted | Days 1 and 25 |
|
|
| Secondary | Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Cmin for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study. | Posted | Day 25 |
|
|
| Secondary | Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Cav for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not reported due to the premature termination of the study. | Posted | Day 25 |
|
|
| Secondary | Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Tmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study. | Posted | Day 25 |
|
|
| Secondary | Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | CL for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study. | Posted | Day 25 |
|
|
| Secondary | Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | t1/2 for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study. | Posted | Day 25 |
|
|
| Secondary | Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) | Rac for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study. | Posted | Day 25 |
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | PF-05231023 100 mg | PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25. | 0 | 2 | 2 | 2 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Eructation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Chest pain | General disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Chills | General disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Puncture site pain | General disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Middle insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment | Treatment-emergent |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment | Events during pre-randomization 7-day diet run-in period |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment | Events during pre-randomization 7-day diet run-in period |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment | Events during pre-randomization 7-day diet run-in period |
|
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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |