Bone Disease, Osteopenia, Osteoporosis
Conditions
Keywords
Phase 1, Osteopenia, RN564
Brief summary
The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
Interventions
BIOLOGICALRN564
Intravenous, single dose with experimental dose
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the lumbar spine, the femoral neck or total hip) * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). * Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that are accessible by DXA.
Exclusion criteria
* Evidence or history of any underlying condition, other than primary osteopenia, that affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism). * Subjects with pre-existing periodontal/dental disease or those who have undergone invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior to Day -1. * If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Days -1, 8, 15, 29, 43, 57, and 85 | — |
| Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Baseline, last observation (up to Day 85) | — |
| Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | Day 1 to Day 85 | Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable. |
| Percentage of Participants With All-Causality AEs by Grade | Day 1 to Day 85 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. |
| Percentage of Participants With Treatment-Related AEs by Grade | Day 1 to Day 85 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Relatedness to drug was assessed by investigator. |
| Number of Participants With Any Laboratory Abnormality | Day 1 to 85 | Criteria for abnormality: hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function: blood urea nitrogen, creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium\>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN), urine casts, granular casts, hyaline casts\>1 LPF; hormones: T4, T3, TSH\<0.8\*LLN. |
| Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Baseline, last observation (up to Day 85) | Median change from baseline in platelets, WBC count, lymphocytes (absolute \[Abs\]), total neutrophils (Abs), basophils (Abs), eosinophils (Abs), and monocytes (Abs) |
| Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | Baseline, last observation (up to Day 85) | — |
| Median Change From Baseline in Hematocrit at Last Observation | Baseline, last observation (up to Day 85) | — |
| Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Baseline, last observation (up to Day 85) | Includes median changes from baseline in total bilirubin, direct bilirubin, indirect bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, and glucose |
| Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Baseline, last observation (up to Day 85) | — |
| Median Change From Baseline in Liver Function Tests at Last Observation | Baseline, last observation (up to Day 85) | Includes median changes in aspartate aminotransferase (AST), alanine aminotransferase (AST), gamma glutamyltransferase (GGT), and alkaline phosphatase |
| Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | Baseline, Last observation (up to Day 85) | — |
| Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Baseline, Last Observation (up to Day 85) | — |
| Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | Baseline, last observation (up to Day 85) | — |
| Median Change From Baseline in T4 at Last Observation | Baseline, last observation (up to Day 85) | — |
| Median Change From Baseline in Urine WBC at Last Observation | Baseline, last observation (up to Day 85) | — |
| Median Change From Baseline in Urine pH at Last Observation | Baseline, last observation (up to Day 85) | — |
| Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | Day 1 up to 85 | Participants with maximum changes from baseline (defined as increases or decreases of greater than or equal to \[≥\]20 mmHg or ≥30 mmHg) in either standing or supine systolic blood pressure (SBP) or diastolic blood pressure (DBP) measured in millimeters mercury (mmHg). |
| Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | Day 1 up to 85 | Participants with maximum changes from baseline (BSL) defined as: ≥25 to 50 percent (%) increase in maximum PR interval or QRS complex; increase from BSL of ≥30 milliseconds (msec) but \<60 msec in corrected QT (QTc) interval or QTcF interval (QTc interval corrected using Fridericia's correction); or increase from BSL ≥60 msec in either QTc interval or QTcF interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | — |
| Clearance (CL) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Volume of Distribution at Steady State (Vss) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Terminal Elimination Half-Life (t1/2) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). |
| Apparent Volume of Distribution (Vz/F) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, data for Vz/F was not collected instead Vss was reported. |
| Percentage Change From Baseline in Total Dickkopf-1 (DKK-1) Concentrations Over Time | Day -1, Day 1 (predose and at end of infusion) and at 2, 4, 8, and 12 hours postdose, and Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57, and 85 | — |
| Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Baseline (Days -1, 1), Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 | Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082 |
| Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 | Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082 |
| Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 | Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082 |
| Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 | Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082 |
| Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 | Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082 |
| Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | Days -1 and 85 | — |
| Femoral Neck BMD at Day 85 | Day 85 | BMD was evaluated by dual energy X-ray absorptiometry (DXA). |
| Femoral Neck T-Score at Day 85 | Day 85 | BMD was evaluated by DXA. T-score was calculated based on actual measured bone density value and is the standardized scores that reflect the standard deviations (SDs) above/below the mean. A BMD T-score of -1.0 or more indicates normal bone density. T-score between -1.0 and -2.5 indicates low bone density known as osteopenia. A T-score of -2.5 or less is diagnostic of osteoporosis. |
| Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Baseline (Day -1), Day 85 | BMD was evaluated by DXA. |
| PK/PD Model Describing the Relationship Between PF-04840082 PK Parameter Estimates/Concentrations and Changes in PD Endpoints | Day 1 to Day 85 | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-04840082 0.3 mg/kg Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 6 |
| PF-04840082 1.0 mg/kg Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 6 |
| PF-04840082 6.0 mg/kg Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 6 |
| PF-04840082 24.0 mg/kg Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 6 |
| PF-04840082 3.0 mg/kg Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 8 |
| PF-04840082 12.0 mg/kg Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 8 |
| PF-04840082 18.0 mg/kg Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 8 |
| Placebo Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours. | 20 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | PF-04840082 0.3 mg/kg | PF-04840082 1.0 mg/kg | PF-04840082 6.0 mg/kg | PF-04840082 24.0 mg/kg | PF-04840082 3.0 mg/kg | PF-04840082 12.0 mg/kg | PF-04840082 18.0 mg/kg | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 6.3 | 65.0 years STANDARD_DEVIATION 9.8 | 61.0 years STANDARD_DEVIATION 4.2 | 63.3 years STANDARD_DEVIATION 5.2 | 61.3 years STANDARD_DEVIATION 5.5 | 63.6 years STANDARD_DEVIATION 7.2 | 61.3 years STANDARD_DEVIATION 5.2 | 62.8 years STANDARD_DEVIATION 5.1 | 62.5 years STANDARD_DEVIATION 5.8 |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 14 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 4 / 6 | 6 / 6 | 5 / 6 | 5 / 8 | 6 / 8 | 6 / 8 | 14 / 20 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 1 / 8 | 0 / 8 | 1 / 20 |
Outcome results
Primary
Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication. Here 0 in the overall number of participants analyzed signifies that data not collected because none of the participants were evaluable for the specified arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | T3 (free) | -0.0 nanograms (ng)/dL |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | T4 (free) | -0.0 nanograms (ng)/dL |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | T3 (free) | -0.0 nanograms (ng)/dL |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | T4 (free) | 0.0 nanograms (ng)/dL |
| Placebo | Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | T3 (free) | -0.0 nanograms (ng)/dL |
| Placebo | Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation | T4 (free) | 0.0 nanograms (ng)/dL |
Primary
Median Change From Baseline in Hematocrit at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | 0.6 percentage of red blood cells |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | 1.4 percentage of red blood cells |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | -0.8 percentage of red blood cells |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | -0.4 percentage of red blood cells |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | 1.0 percentage of red blood cells |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | -2.4 percentage of red blood cells |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Hematocrit at Last Observation | 0.5 percentage of red blood cells |
| Placebo | Median Change From Baseline in Hematocrit at Last Observation | -0.8 percentage of red blood cells |
Primary
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | -0.5 grams/deciliter (g/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.3 grams/deciliter (g/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | -0.3 grams/deciliter (g/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | -0.3 grams/deciliter (g/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.6 grams/deciliter (g/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | -0.2 grams/deciliter (g/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | -0.0 grams/deciliter (g/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.6 grams/deciliter (g/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | -0.1 grams/deciliter (g/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.1 grams/deciliter (g/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | 0.1 grams/deciliter (g/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | 0.0 grams/deciliter (g/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.1 grams/deciliter (g/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | 0.2 grams/deciliter (g/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | 0.2 grams/deciliter (g/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.8 grams/deciliter (g/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | -0.3 grams/deciliter (g/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | -0.3 grams/deciliter (g/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | -0.0 grams/deciliter (g/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.2 grams/deciliter (g/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | 0.0 grams/deciliter (g/dL) |
| Placebo | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Hemoglobin (HGB) | -0.4 grams/deciliter (g/dL) |
| Placebo | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Albumin | -0.1 grams/deciliter (g/dL) |
| Placebo | Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation | Total Protein | -0.2 grams/deciliter (g/dL) |
Primary
Median Change From Baseline in Liver Function Tests at Last Observation
Includes median changes in aspartate aminotransferase (AST), alanine aminotransferase (AST), gamma glutamyltransferase (GGT), and alkaline phosphatase
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | 0 international units (IU)/L |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | 1 international units (IU)/L |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | -8 international units (IU)/L |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | -1 international units (IU)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | -6 international units (IU)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | -3 international units (IU)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | -5 international units (IU)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | 0 international units (IU)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | 2 international units (IU)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | 4 international units (IU)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | -2 international units (IU)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | 1 international units (IU)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | 10 international units (IU)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | 1 international units (IU)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | -1 international units (IU)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | -2 international units (IU)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | 1 international units (IU)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | 4 international units (IU)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | 7 international units (IU)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | 2 international units (IU)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | -3 international units (IU)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | 1 international units (IU)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | -2 international units (IU)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | 1 international units (IU)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | -8 international units (IU)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | -1 international units (IU)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | -5 international units (IU)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | 3 international units (IU)/L |
| Placebo | Median Change From Baseline in Liver Function Tests at Last Observation | Alkaline Phosphatase | -3 international units (IU)/L |
| Placebo | Median Change From Baseline in Liver Function Tests at Last Observation | Aminotransferase (AST) | 1 international units (IU)/L |
| Placebo | Median Change From Baseline in Liver Function Tests at Last Observation | Alanine Aminotransferase (ALT) | 0 international units (IU)/L |
| Placebo | Median Change From Baseline in Liver Function Tests at Last Observation | Gamma GT | -1 international units (IU)/L |
Primary
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Median change from baseline in platelets, WBC count, lymphocytes (absolute \[Abs\]), total neutrophils (Abs), basophils (Abs), eosinophils (Abs), and monocytes (Abs)
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.78 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.03 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | -0.10 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.8 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | 8 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | -0.10 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | -0.04 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | -9 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.2 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | -0.06 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | 0.04 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | 0.06 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.34 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | 7 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.04 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.5 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | 4 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.9 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | -0.06 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.51 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | -0.04 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.12 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | 0.03 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.1 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | 0.07 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | -3 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | -0.05 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.61 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | -31 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.8 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | -0.03 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | 0.0 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | 0.09 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | -5 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.11 10^3 cells/millimeter cube (mm^3) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Platelets | -6 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Basophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | White Blood Cell Count | -0.4 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Monocytes (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Lymphocytes (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Eosinophils (Abs) | 0.00 10^3 cells/millimeter cube (mm^3) |
| Placebo | Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation | Total Neutrophils (Abs) | -0.35 10^3 cells/millimeter cube (mm^3) |
Primary
Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | -0.05 10^6 cells/mm^3 |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | -0.07 10^6 cells/mm^3 |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | -0.14 10^6 cells/mm^3 |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | -0.10 10^6 cells/mm^3 |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | 0.05 10^6 cells/mm^3 |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | -0.30 10^6 cells/mm^3 |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | 0.06 10^6 cells/mm^3 |
| Placebo | Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation | -0.07 10^6 cells/mm^3 |
Primary
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Includes median changes from baseline in total bilirubin, direct bilirubin, indirect bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, and glucose
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | -11 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | -4.7 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | -1.0 milligrams/dL (mg/dL) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | 2 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | -0.0 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | 5.0 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | 1 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | -3.5 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | 3.8 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | 0.1 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | 3 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | -2.1 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | -1 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.1 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | -11 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | 1.2 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | 1.2 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | 0.1 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | -1 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.1 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | -0.2 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.1 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | 0.2 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | 1.3 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | 0.0 milligrams/dL (mg/dL) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | -0.2 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Magnesium | 0.0 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Blood Urea Nitrogen (BUN) | -0.4 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Indirect Bilirubin | -0.0 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Calcium | -0.2 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Glucose | 0 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Direct Bilirubin | 0.0 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Uric Acid | -0.2 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Creatinine | 0.0 milligrams/dL (mg/dL) |
| Placebo | Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation | Total Bilirubin | 0.0 milligrams/dL (mg/dL) |
Primary
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Time frame: Baseline, Last Observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | -17 units (U)/L |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | -1 units (U)/L |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | 5 units (U)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | 5 units (U)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | -1 units (U)/L |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | 21 units (U)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | -8 units (U)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | -43 units (U)/L |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | 4 units (U)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | 13 units (U)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | 1 units (U)/L |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | 14 units (U)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | 7 units (U)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | 1 units (U)/L |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | -7 units (U)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | -1 units (U)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | -11 units (U)/L |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | -8 units (U)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | -12 units (U)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | 4 units (U)/L |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | -3 units (U)/L |
| Placebo | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Creatine Kinase (CK) | -16 units (U)/L |
| Placebo | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Amylase | 0 units (U)/L |
| Placebo | Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation | Lipase | 4 units (U)/L |
Primary
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | -1 milliequivalents (mEq)/liter (L) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | 0.1 milliequivalents (mEq)/liter (L) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | -1 milliequivalents (mEq)/liter (L) |
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | 0.2 milliequivalents (mEq)/liter (L) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | 0.3 milliequivalents (mEq)/liter (L) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | 0.0 milliequivalents (mEq)/liter (L) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | -0 milliequivalents (mEq)/liter (L) |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | 0 milliequivalents (mEq)/liter (L) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | -1 milliequivalents (mEq)/liter (L) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | 0.6 milliequivalents (mEq)/liter (L) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | 0.1 milliequivalents (mEq)/liter (L) |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | -1 milliequivalents (mEq)/liter (L) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | -1 milliequivalents (mEq)/liter (L) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | 0.2 milliequivalents (mEq)/liter (L) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | 0 milliequivalents (mEq)/liter (L) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | -1.5 milliequivalents (mEq)/liter (L) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | 0.0 milliequivalents (mEq)/liter (L) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | 1 milliequivalents (mEq)/liter (L) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | 0.3 milliequivalents (mEq)/liter (L) |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | 0 milliequivalents (mEq)/liter (L) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | -0.3 milliequivalents (mEq)/liter (L) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | 2 milliequivalents (mEq)/liter (L) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | -0.3 milliequivalents (mEq)/liter (L) |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | 0 milliequivalents (mEq)/liter (L) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | -0.3 milliequivalents (mEq)/liter (L) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | -1 milliequivalents (mEq)/liter (L) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | -0 milliequivalents (mEq)/liter (L) |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | -0.2 milliequivalents (mEq)/liter (L) |
| Placebo | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Potassium | -0.1 milliequivalents (mEq)/liter (L) |
| Placebo | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Chloride | -0 milliequivalents (mEq)/liter (L) |
| Placebo | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Bicarbonate (venous) | 0.0 milliequivalents (mEq)/liter (L) |
| Placebo | Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation | Sodium | 0 milliequivalents (mEq)/liter (L) |
Primary
Median Change From Baseline in T4 at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication. Here 0 in the overall number of participants analyzed signifies that data not collected because none of the participants were evaluable for the specified arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in T4 at Last Observation | 0.3 micrograms (mcg)/dL |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in T4 at Last Observation | 0.9 micrograms (mcg)/dL |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in T4 at Last Observation | -1.6 micrograms (mcg)/dL |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in T4 at Last Observation | 0.0 micrograms (mcg)/dL |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in T4 at Last Observation | -0.3 micrograms (mcg)/dL |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in T4 at Last Observation | 0.2 micrograms (mcg)/dL |
| Placebo | Median Change From Baseline in T4 at Last Observation | 0.1 micrograms (mcg)/dL |
Primary
Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation
Time frame: Baseline, Last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 0 micro IU (mIU)/mL |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 0 micro IU (mIU)/mL |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 0 micro IU (mIU)/mL |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | -0 micro IU (mIU)/mL |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 0 micro IU (mIU)/mL |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 0 micro IU (mIU)/mL |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 1 micro IU (mIU)/mL |
| Placebo | Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation | 0 micro IU (mIU)/mL |
Primary
Median Change From Baseline in Urine pH at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Median Change From Baseline in Urine pH at Last Observation | 0.3 pH |
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Urine pH at Last Observation | 0.7 pH |
| PF-04840082 6.0 mg/kg | Median Change From Baseline in Urine pH at Last Observation | 0.3 pH |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Urine pH at Last Observation | 0.0 pH |
| PF-04840082 3.0 mg/kg | Median Change From Baseline in Urine pH at Last Observation | 0.6 pH |
| PF-04840082 12.0 mg/kg | Median Change From Baseline in Urine pH at Last Observation | -0.3 pH |
| PF-04840082 18.0 mg/kg | Median Change From Baseline in Urine pH at Last Observation | 0.0 pH |
| Placebo | Median Change From Baseline in Urine pH at Last Observation | 0.3 pH |
Primary
Median Change From Baseline in Urine WBC at Last Observation
Time frame: Baseline, last observation (up to Day 85)
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication. Here 0 in the overall number of participants analyzed signifies that data not collected because none of the participants were evaluable for the specified arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 1.0 mg/kg | Median Change From Baseline in Urine WBC at Last Observation | -1.0 /high-powered field (HPF) |
| PF-04840082 24.0 mg/kg | Median Change From Baseline in Urine WBC at Last Observation | 0.0 /high-powered field (HPF) |
| Placebo | Median Change From Baseline in Urine WBC at Last Observation | -1.0 /high-powered field (HPF) |
Primary
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
Participants with maximum changes from baseline (defined as increases or decreases of greater than or equal to \[≥\]20 mmHg or ≥30 mmHg) in either standing or supine systolic blood pressure (SBP) or diastolic blood pressure (DBP) measured in millimeters mercury (mmHg).
Time frame: Day 1 up to 85
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 0 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 0 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 0 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 3 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 3 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 0 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 1 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 1 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 1 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 1 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 3 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 1 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 1 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 1 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 1 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 1 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 1 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 3 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 1 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 1 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 3 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 2 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 1 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 1 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 1 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 0 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in supine SBP | 1 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in supine DBP | 1 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in standing SBP | 4 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg increase from baseline in standing DBP | 0 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in standing DBP | 3 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥20 mmHg decrease from baseline in supine DBP | 2 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg decrease from baseline in supine SBP | 3 Participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure | ≥30 mmHg increase from baseline in standing SBP | 2 Participants |
Primary
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Participants with maximum changes from baseline (BSL) defined as: ≥25 to 50 percent (%) increase in maximum PR interval or QRS complex; increase from BSL of ≥30 milliseconds (msec) but \<60 msec in corrected QT (QTc) interval or QTcF interval (QTc interval corrected using Fridericia's correction); or increase from BSL ≥60 msec in either QTc interval or QTcF interval.
Time frame: Day 1 up to 85
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 1 participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 2 participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 1 participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 1 participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 1 participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 0 participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 0 participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTcF interval | 1 participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTcF interval | 1 participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in PR interval | 0 participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥60 msec increase from BSL in QTc interval | 0 participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥25/50% increase from BSL in QRS complex | 0 participants |
| Placebo | Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | ≥30 to <60 msec increase from BSL in QTc interval | 0 participants |
Primary
Number of Participants With Any Laboratory Abnormality
Criteria for abnormality: hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function: blood urea nitrogen, creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium\>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN), urine casts, granular casts, hyaline casts\>1 LPF; hormones: T4, T3, TSH\<0.8\*LLN.
Time frame: Day 1 to 85
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Number of Participants With Any Laboratory Abnormality | 3 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Any Laboratory Abnormality | 3 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Any Laboratory Abnormality | 4 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Any Laboratory Abnormality | 1 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Any Laboratory Abnormality | 3 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Any Laboratory Abnormality | 4 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Any Laboratory Abnormality | 4 Participants |
| Placebo | Number of Participants With Any Laboratory Abnormality | 12 Participants |
Primary
Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)
Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.
Time frame: Day 1 to Day 85
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
| Placebo | Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Time frame: Days -1, 8, 15, 29, 43, 57, and 85
Population: Safety Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 1 Participants |
| PF-04840082 0.3 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 0 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 1 Participants |
| PF-04840082 1.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 1 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 0 Participants |
| PF-04840082 6.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 0 Participants |
| PF-04840082 24.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 1 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 0 Participants |
| PF-04840082 3.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 0 Participants |
| PF-04840082 12.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 57 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day -1 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 85 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 43 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 15 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 8 | 0 Participants |
| PF-04840082 18.0 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit | Day 29 | 0 Participants |
Primary
Percentage of Participants With All-Causality AEs by Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Time frame: Day 1 to Day 85
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 100.0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 50.0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 16.7 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 100.0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 66.7 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 16.7 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 62.5 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 12.5 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 25.0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 37.5 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 62.5 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 12.5 percentage of participants |
| Placebo | Percentage of Participants With All-Causality AEs by Grade | Grade 4 | 0 percentage of participants |
| Placebo | Percentage of Participants With All-Causality AEs by Grade | Grade 3 | 0 percentage of participants |
| Placebo | Percentage of Participants With All-Causality AEs by Grade | Missing/Unknown | 0 percentage of participants |
| Placebo | Percentage of Participants With All-Causality AEs by Grade | Grade 5 | 0 percentage of participants |
| Placebo | Percentage of Participants With All-Causality AEs by Grade | Grade 1 | 60.0 percentage of participants |
| Placebo | Percentage of Participants With All-Causality AEs by Grade | Grade 2 | 10.0 percentage of participants |
Primary
Percentage of Participants With Treatment-Related AEs by Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Relatedness to drug was assessed by investigator.
Time frame: Day 1 to Day 85
Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 50.0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 0.3 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 16.7 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 16.7 percentage of participants |
| PF-04840082 1.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 50.0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 6.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 24.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 33.3 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 50.0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 3.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 12.5 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 12.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 37.5 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| PF-04840082 18.0 mg/kg | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Related AEs by Grade | Grade 3 | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Related AEs by Grade | Grade 4 | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Related AEs by Grade | Grade 1 | 20.0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Related AEs by Grade | Grade 5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Related AEs by Grade | Grade 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Related AEs by Grade | Missing/Unknown | 0 percentage of participants |
Secondary
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, data for Vz/F was not collected instead Vss was reported.
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, Vz/F was not reported. Instead, Vss was reported.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | NA mcg*h/mL | — |
| PF-04840082 1.0 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | 8655 mcg*h/mL | Standard Deviation 1390.4 |
| PF-04840082 6.0 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | 97010 mcg*h/mL | Standard Deviation 18085 |
| PF-04840082 24.0 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | NA mcg*h/mL | — |
| PF-04840082 3.0 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | 36270 mcg*h/mL | Standard Deviation 5387 |
| PF-04840082 12.0 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | 192600 mcg*h/mL | Standard Deviation 13512 |
| PF-04840082 18.0 mg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | 323800 mcg*h/mL | Standard Deviation 34395 |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: Pharmacokinetic (PK) Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 1175 mcg*h/mL | Standard Deviation 197.79 |
| PF-04840082 1.0 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 7588 mcg*h/mL | Standard Deviation 1297.1 |
| PF-04840082 6.0 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 86360 mcg*h/mL | Standard Deviation 12846 |
| PF-04840082 24.0 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 348800 mcg*h/mL | Standard Deviation 43230 |
| PF-04840082 3.0 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 33960 mcg*h/mL | Standard Deviation 4326.5 |
| PF-04840082 12.0 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 171100 mcg*h/mL | Standard Deviation 12762 |
| PF-04840082 18.0 mg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 269600 mcg*h/mL | Standard Deviation 27289 |
Secondary
Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure and 0 in the overall number of participants analyzed signifies that data not collected because none of the participants were evaluable for the specified arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 1.0 mg/kg | Clearance (CL) | 7.647 mL/hr | Standard Deviation 1.9804 |
| PF-04840082 6.0 mg/kg | Clearance (CL) | 4.011 mL/hr | Standard Deviation 0.72503 |
| PF-04840082 3.0 mg/kg | Clearance (CL) | 5.729 mL/hr | Standard Deviation 1.2399 |
| PF-04840082 12.0 mg/kg | Clearance (CL) | 4.248 mL/hr | Standard Deviation 0.77445 |
| PF-04840082 18.0 mg/kg | Clearance (CL) | 3.587 mL/hr | Standard Deviation 0.32146 |
Secondary
Femoral Neck BMD at Day 85
BMD was evaluated by dual energy X-ray absorptiometry (DXA).
Time frame: Day 85
Population: PD Analysis Population. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Femoral Neck BMD at Day 85 | 0.7308 Gram per centimeter square | Standard Deviation 0.09688 |
| PF-04840082 1.0 mg/kg | Femoral Neck BMD at Day 85 | 0.8357 Gram per centimeter square | Standard Deviation 0.09877 |
| PF-04840082 6.0 mg/kg | Femoral Neck BMD at Day 85 | 0.8135 Gram per centimeter square | Standard Deviation 0.101 |
| PF-04840082 24.0 mg/kg | Femoral Neck BMD at Day 85 | 0.7954 Gram per centimeter square | Standard Deviation 0.10295 |
| PF-04840082 3.0 mg/kg | Femoral Neck BMD at Day 85 | 0.8666 Gram per centimeter square | Standard Deviation 0.11867 |
| PF-04840082 12.0 mg/kg | Femoral Neck BMD at Day 85 | 0.7185 Gram per centimeter square | Standard Deviation 0.07402 |
| PF-04840082 18.0 mg/kg | Femoral Neck BMD at Day 85 | 0.8993 Gram per centimeter square | Standard Deviation 0.06102 |
| Placebo | Femoral Neck BMD at Day 85 | 0.8362 Gram per centimeter square | Standard Deviation 0.11301 |
Secondary
Femoral Neck T-Score at Day 85
BMD was evaluated by DXA. T-score was calculated based on actual measured bone density value and is the standardized scores that reflect the standard deviations (SDs) above/below the mean. A BMD T-score of -1.0 or more indicates normal bone density. T-score between -1.0 and -2.5 indicates low bone density known as osteopenia. A T-score of -2.5 or less is diagnostic of osteoporosis.
Time frame: Day 85
Population: PD Analysis Population. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Femoral Neck T-Score at Day 85 | -1.2833 T-score | Standard Deviation 0.81833 |
| PF-04840082 1.0 mg/kg | Femoral Neck T-Score at Day 85 | -0.7333 T-score | Standard Deviation 1.55906 |
| PF-04840082 6.0 mg/kg | Femoral Neck T-Score at Day 85 | -1.2833 T-score | Standard Deviation 0.36009 |
| PF-04840082 24.0 mg/kg | Femoral Neck T-Score at Day 85 | -1.7600 T-score | Standard Deviation 0.70922 |
| PF-04840082 3.0 mg/kg | Femoral Neck T-Score at Day 85 | -0.9324 T-score | Standard Deviation 1.14262 |
| PF-04840082 12.0 mg/kg | Femoral Neck T-Score at Day 85 | -1.6500 T-score | Standard Deviation 0.74066 |
| PF-04840082 18.0 mg/kg | Femoral Neck T-Score at Day 85 | -0.8466 T-score | Standard Deviation 0.73385 |
| Placebo | Femoral Neck T-Score at Day 85 | -1.2278 T-score | Standard Deviation 0.57477 |
Secondary
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Maximum Observed Serum Concentration (Cmax) | 9.580 mcg/mL | Standard Deviation 0.69545 |
| PF-04840082 1.0 mg/kg | Maximum Observed Serum Concentration (Cmax) | 29.20 mcg/mL | Standard Deviation 4.3353 |
| PF-04840082 6.0 mg/kg | Maximum Observed Serum Concentration (Cmax) | 205.8 mcg/mL | Standard Deviation 29.743 |
| PF-04840082 24.0 mg/kg | Maximum Observed Serum Concentration (Cmax) | 687.3 mcg/mL | Standard Deviation 69.032 |
| PF-04840082 3.0 mg/kg | Maximum Observed Serum Concentration (Cmax) | 92.05 mcg/mL | Standard Deviation 27.124 |
| PF-04840082 12.0 mg/kg | Maximum Observed Serum Concentration (Cmax) | 409.6 mcg/mL | Standard Deviation 56.592 |
| PF-04840082 18.0 mg/kg | Maximum Observed Serum Concentration (Cmax) | 549.4 mcg/mL | Standard Deviation 60.738 |
Secondary
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
BMD was evaluated by DXA.
Time frame: Baseline (Day -1), Day 85
Population: PD Analysis Population; Here, Overall number of participants analyzed=number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | -1.014 percentage change | Standard Deviation 4.1485 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | -0.138 percentage change | Standard Deviation 3.3241 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | -8.608 percentage change | Standard Deviation 19.6096 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | 0.716 percentage change | Standard Deviation 6.9188 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | 2.767 percentage change | Standard Deviation 6.7007 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | 1.673 percentage change | Standard Deviation 5.2845 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | -0.760 percentage change | Standard Deviation 2.0682 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | -1.253 percentage change | Standard Deviation 3.0603 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | -1.545 percentage change | Standard Deviation 3.8933 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | 7.744 percentage change | Standard Deviation 13.4882 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | 1.226 percentage change | Standard Deviation 2.5319 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | 3.131 percentage change | Standard Deviation 2.8903 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | -0.823 percentage change | Standard Deviation 7.7854 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | 1.387 percentage change | Standard Deviation 3.3849 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | 1.207 percentage change | Standard Deviation 3.0197 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | -2.595 percentage change | Standard Deviation 2.62 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | -1.223 percentage change | Standard Deviation 4.6806 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | -2.087 percentage change | Standard Deviation 2.1496 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | 6.485 percentage change | Standard Deviation 7.5097 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | 7.542 percentage change | Standard Deviation 7.5636 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | 6.944 percentage change | Standard Deviation 6.4528 |
| Placebo | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Forearm Total BMD | 2.439 percentage change | Standard Deviation 12.9063 |
| Placebo | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Ulna BMD | -1.101 percentage change | Standard Deviation 7.2397 |
| Placebo | Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 | Radius BMD | -0.610 percentage change | Standard Deviation 6.6493 |
Secondary
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
Time frame: Days -1 and 85
Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | -4.096 percentage change | Standard Deviation 7.5769 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | -1.356 percentage change | Standard Deviation 3.3947 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | -1.908 percentage change | Standard Deviation 4.7541 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | 1.467 percentage change | Standard Deviation 5.368 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | -1.441 percentage change | Standard Deviation 6.4764 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | -0.816 percentage change | Standard Deviation 5.8942 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | 2.443 percentage change | Standard Deviation 6.4076 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | 0.975 percentage change | Standard Deviation 4.5713 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | -1.172 percentage change | Standard Deviation 6.4637 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | 3.820 percentage change | Standard Deviation 2.8253 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | 0.454 percentage change | Standard Deviation 1.6845 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | -0.914 percentage change | Standard Deviation 2.2948 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | -0.725 percentage change | Standard Deviation 2.8558 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | -1.553 percentage change | Standard Deviation 3.7424 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | 0.237 percentage change | Standard Deviation 3.0146 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | -3.332 percentage change | Standard Deviation 4.5817 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | -0.918 percentage change | Standard Deviation 5.8689 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | -1.377 percentage change | Standard Deviation 6.5 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | -0.200 percentage change | Standard Deviation 8.7398 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | 1.228 percentage change | Standard Deviation 7.7207 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | 0.942 percentage change | Standard Deviation 2.889 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | 0.437 percentage change | Standard Deviation 6.1468 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | -0.940 percentage change | Standard Deviation 2.156 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | -0.171 percentage change | Standard Deviation 3.6823 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | 0.144 percentage change | Standard Deviation 2.1232 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | 0.973 percentage change | Standard Deviation 5.3894 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | 0.470 percentage change | Standard Deviation 5.2763 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | -0.890 percentage change | Standard Deviation 5.0854 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | -0.305 percentage change | Standard Deviation 4.2402 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | 0.095 percentage change | Standard Deviation 3.425 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | 0.793 percentage change | Standard Deviation 4.8739 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | -1.033 percentage change | Standard Deviation 3.4547 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | 0.609 percentage change | Standard Deviation 3.8245 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | 0.206 percentage change | Standard Deviation 3.2457 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | 0.171 percentage change | Standard Deviation 3.7706 |
| Placebo | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine Total L1-L4 BMD | -0.794 percentage change | Standard Deviation 2.2182 |
| Placebo | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L4 BMD | -1.288 percentage change | Standard Deviation 3.6274 |
| Placebo | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L1 BMD | -0.439 percentage change | Standard Deviation 3.7668 |
| Placebo | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L3 BMD | -1.330 percentage change | Standard Deviation 3.1723 |
| Placebo | Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 | AP Spine L2 BMD | 1.060 percentage change | Standard Deviation 3.9478 |
Secondary
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | 1.621 percentage change | Standard Deviation 11.321 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | -4.280 percentage change | Standard Deviation 9.5383 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | 17.180 percentage change | Standard Deviation 7.2047 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 11.455 percentage change | Standard Deviation 7.676 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | 6.038 percentage change | Standard Deviation 4.8726 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -6.185 percentage change | Standard Deviation 6.3059 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 6.766 percentage change | Standard Deviation 4.2535 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | 0.929 percentage change | Standard Deviation 8.4449 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | 8.418 percentage change | Standard Deviation 9.2449 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 3.622 percentage change | Standard Deviation 5.8263 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | 19.200 percentage change | Standard Deviation 6.8095 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | 12.815 percentage change | Standard Deviation 7.1986 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 0.848 percentage change | Standard Deviation 15.5889 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | 2.592 percentage change | Standard Deviation 6.4759 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | 10.798 percentage change | Standard Deviation 16.4632 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | 0.331 percentage change | Standard Deviation 6.4424 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 6.526 percentage change | Standard Deviation 6.5755 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | 17.688 percentage change | Standard Deviation 18.6277 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | -0.234 percentage change | Standard Deviation 8.353 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 11.610 percentage change | Standard Deviation 14.5871 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -2.849 percentage change | Standard Deviation 3.8567 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | 7.438 percentage change | Standard Deviation 7.8948 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | 15.884 percentage change | Standard Deviation 17.1866 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | 0.729 percentage change | Standard Deviation 5.9355 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | 6.823 percentage change | Standard Deviation 9.1449 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 6.179 percentage change | Standard Deviation 9.1027 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 7.169 percentage change | Standard Deviation 19.2122 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | 4.848 percentage change | Standard Deviation 10.6591 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -0.796 percentage change | Standard Deviation 7.4823 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 10.813 percentage change | Standard Deviation 12.7424 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | 5.189 percentage change | Standard Deviation 8.7365 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | 9.205 percentage change | Standard Deviation 15.8163 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | 1.767 percentage change | Standard Deviation 8.0676 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | 7.156 percentage change | Standard Deviation 8.601 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | 4.684 percentage change | Standard Deviation 14.001 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | 4.513 percentage change | Standard Deviation 12.9814 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | 5.260 percentage change | Standard Deviation 9.7094 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -7.570 percentage change | Standard Deviation 9.2328 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | 0.125 percentage change | Standard Deviation 7.8541 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | 2.074 percentage change | Standard Deviation 9.4077 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | 0.313 percentage change | Standard Deviation 3.9781 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 10.983 percentage change | Standard Deviation 10.9069 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | 9.570 percentage change | Standard Deviation 11.1603 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | 13.649 percentage change | Standard Deviation 7.9592 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | 9.652 percentage change | Standard Deviation 6.5596 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 9.018 percentage change | Standard Deviation 8.0671 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 0.851 percentage change | Standard Deviation 18.5419 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | 8.344 percentage change | Standard Deviation 5.4401 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | -1.368 percentage change | Standard Deviation 16.3976 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | 3.469 percentage change | Standard Deviation 15.0685 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | 7.952 percentage change | Standard Deviation 10.8748 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | 13.720 percentage change | Standard Deviation 17.566 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | 0.558 percentage change | Standard Deviation 8.7457 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 3.291 percentage change | Standard Deviation 9.4929 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 9.197 percentage change | Standard Deviation 19.9274 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | 0.160 percentage change | Standard Deviation 7.3513 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 8.902 percentage change | Standard Deviation 16.7039 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -0.796 percentage change | Standard Deviation 3.6143 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | 0.038 percentage change | Standard Deviation 5.5704 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | 2.460 percentage change | Standard Deviation 5.9179 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | 0.052 percentage change | Standard Deviation 6.5211 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | 2.468 percentage change | Standard Deviation 12.5723 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | -2.533 percentage change | Standard Deviation 7.4853 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | -2.158 percentage change | Standard Deviation 10.6419 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | -0.313 percentage change | Standard Deviation 14.4515 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | -0.917 percentage change | Standard Deviation 14.9214 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | -5.825 percentage change | Standard Deviation 16.8764 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 0.731 percentage change | Standard Deviation 11.6516 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | -7.289 percentage change | Standard Deviation 5.5333 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | -10.431 percentage change | Standard Deviation 14.3542 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -6.334 percentage change | Standard Deviation 7.9459 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 4.573 percentage change | Standard Deviation 9.0742 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | 2.937 percentage change | Standard Deviation 13.2892 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 5.795 percentage change | Standard Deviation 15.458 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 0.676 percentage change | Standard Deviation 16.3864 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | -4.873 percentage change | Standard Deviation 14.7151 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -3.927 percentage change | Standard Deviation 5.4622 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | -2.325 percentage change | Standard Deviation 16.0997 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | -0.332 percentage change | Standard Deviation 13.5092 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | -4.115 percentage change | Standard Deviation 16.0237 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | 3.230 percentage change | Standard Deviation 16.5615 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | 0.048 percentage change | Standard Deviation 8.8057 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | 1.002 percentage change | Standard Deviation 12.9844 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | 7.332 percentage change | Standard Deviation 12.0581 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 36 | -0.863 percentage change | Standard Deviation 13.2753 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 3 | -3.010 percentage change | Standard Deviation 8.1557 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 43 | 0.977 percentage change | Standard Deviation 13.0563 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 5 | -0.124 percentage change | Standard Deviation 10.4404 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 22 | -2.589 percentage change | Standard Deviation 14.3755 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 2 | -3.934 percentage change | Standard Deviation 7.4244 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 15 | -5.780 percentage change | Standard Deviation 12.2364 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 57 | 0.155 percentage change | Standard Deviation 11.9164 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 4 | -0.876 percentage change | Standard Deviation 7.4064 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 29 | -4.472 percentage change | Standard Deviation 15.3127 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 8 | -0.594 percentage change | Standard Deviation 10.8209 |
| Placebo | Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time | Day 85 | 3.076 percentage change | Standard Deviation 13.2167 |
Secondary
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | -8.039 percentage change | Standard Deviation 9.8536 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | -5.989 percentage change | Standard Deviation 16.6472 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | 1.090 percentage change | Standard Deviation 16.2461 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | -10.411 percentage change | Standard Deviation 13.5145 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 3.467 percentage change | Standard Deviation 7.6528 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | -12.864 percentage change | Standard Deviation 9.2562 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | -9.972 percentage change | Standard Deviation 14.6179 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | -6.741 percentage change | Standard Deviation 8.4135 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | -4.472 percentage change | Standard Deviation 7.9083 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | 4.934 percentage change | Standard Deviation 19.298 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | -9.424 percentage change | Standard Deviation 10.3618 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | -9.903 percentage change | Standard Deviation 18.8829 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | -11.367 percentage change | Standard Deviation 8.0673 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | -8.980 percentage change | Standard Deviation 16.1776 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | -5.584 percentage change | Standard Deviation 19.4223 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | 4.296 percentage change | Standard Deviation 15.1105 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | 1.482 percentage change | Standard Deviation 14.9042 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | -1.360 percentage change | Standard Deviation 11.7081 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | 8.380 percentage change | Standard Deviation 20.4009 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 6.218 percentage change | Standard Deviation 19.6492 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | 0.422 percentage change | Standard Deviation 11.8856 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | -8.866 percentage change | Standard Deviation 19.8682 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | -14.092 percentage change | Standard Deviation 14.6006 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | -7.907 percentage change | Standard Deviation 8.5077 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | 33.724 percentage change | Standard Deviation 44.0981 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | 24.010 percentage change | Standard Deviation 20.2593 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | 26.589 percentage change | Standard Deviation 18.1507 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | 25.799 percentage change | Standard Deviation 20.0022 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | 13.993 percentage change | Standard Deviation 17.1176 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | 27.694 percentage change | Standard Deviation 23.7259 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | 15.999 percentage change | Standard Deviation 18.0461 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | 16.416 percentage change | Standard Deviation 6.2517 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | 9.864 percentage change | Standard Deviation 20.186 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | 8.572 percentage change | Standard Deviation 24.7327 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | 18.554 percentage change | Standard Deviation 33.9325 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 26.444 percentage change | Standard Deviation 16.5991 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | -8.871 percentage change | Standard Deviation 19.2661 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | -0.322 percentage change | Standard Deviation 8.0655 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | -2.931 percentage change | Standard Deviation 10.3678 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | 11.628 percentage change | Standard Deviation 9.2015 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | -17.477 percentage change | Standard Deviation 9.9364 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | -6.834 percentage change | Standard Deviation 9.6209 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | -14.097 percentage change | Standard Deviation 18.5865 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | -9.145 percentage change | Standard Deviation 22.6658 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | -0.529 percentage change | Standard Deviation 14.2914 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 9.644 percentage change | Standard Deviation 6.9192 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | 1.130 percentage change | Standard Deviation 15.5004 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | -13.721 percentage change | Standard Deviation 13.009 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | -19.376 percentage change | Standard Deviation 15.1382 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 0.024 percentage change | Standard Deviation 14.1443 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | -0.980 percentage change | Standard Deviation 17.343 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | -5.354 percentage change | Standard Deviation 25.1017 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | 0.462 percentage change | Standard Deviation 27.4688 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | -8.233 percentage change | Standard Deviation 31.2067 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | -12.009 percentage change | Standard Deviation 14.0871 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | -10.414 percentage change | Standard Deviation 10.1372 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | -13.549 percentage change | Standard Deviation 16.1342 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | -1.681 percentage change | Standard Deviation 19.1395 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | 3.519 percentage change | Standard Deviation 29.4764 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | -4.368 percentage change | Standard Deviation 22.8715 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | -14.378 percentage change | Standard Deviation 12.3489 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | -4.800 percentage change | Standard Deviation 14.0773 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | -6.551 percentage change | Standard Deviation 16.7397 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | -8.608 percentage change | Standard Deviation 17.6558 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | -12.647 percentage change | Standard Deviation 15.1312 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 4.756 percentage change | Standard Deviation 16.3268 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | -3.761 percentage change | Standard Deviation 17.8403 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | -5.499 percentage change | Standard Deviation 21.6249 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | 6.211 percentage change | Standard Deviation 24.104 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | -6.819 percentage change | Standard Deviation 30.206 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | -12.078 percentage change | Standard Deviation 17.7073 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | -7.134 percentage change | Standard Deviation 28.077 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | -4.586 percentage change | Standard Deviation 19.8401 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | -5.356 percentage change | Standard Deviation 22.741 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | -6.296 percentage change | Standard Deviation 17.1832 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | 2.090 percentage change | Standard Deviation 15.8885 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | 11.802 percentage change | Standard Deviation 25.1567 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | 5.776 percentage change | Standard Deviation 12.9204 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | 3.407 percentage change | Standard Deviation 20.9937 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | 14.878 percentage change | Standard Deviation 17.6179 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | -9.104 percentage change | Standard Deviation 18.4964 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | -10.254 percentage change | Standard Deviation 16.105 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 7.585 percentage change | Standard Deviation 8.7674 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | -4.843 percentage change | Standard Deviation 14.4791 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 22 | 12.395 percentage change | Standard Deviation 42.694 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 36 | 1.337 percentage change | Standard Deviation 21.1947 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 15 | 7.668 percentage change | Standard Deviation 19.2344 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 57 | 2.932 percentage change | Standard Deviation 23.9281 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 85 | 2.521 percentage change | Standard Deviation 18.3823 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 4 | 7.499 percentage change | Standard Deviation 15.6537 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 2 | 2.372 percentage change | Standard Deviation 27.8091 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 43 | 1.531 percentage change | Standard Deviation 14.7672 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 29 | 2.626 percentage change | Standard Deviation 16.7445 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 5 | 3.983 percentage change | Standard Deviation 20.4928 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 3 | 9.334 percentage change | Standard Deviation 15.7981 |
| Placebo | Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time | Day 8 | 1.488 percentage change | Standard Deviation 15.694 |
Secondary
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -7.765 percentage change from baseline | Standard Deviation 4.8847 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | -17.167 percentage change from baseline | Standard Deviation 5.7802 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | -0.445 percentage change from baseline | Standard Deviation 22.3404 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | 2.287 percentage change from baseline | Standard Deviation 20.6325 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | 5.677 percentage change from baseline | Standard Deviation 6.5738 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | -0.026 percentage change from baseline | Standard Deviation 19.4086 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | -3.067 percentage change from baseline | Standard Deviation 17.7754 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -4.602 percentage change from baseline | Standard Deviation 14.2023 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 5.301 percentage change from baseline | Standard Deviation 9.812 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | -7.690 percentage change from baseline | Standard Deviation 21.3058 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | -9.634 percentage change from baseline | Standard Deviation 9.5923 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 2.826 percentage change from baseline | Standard Deviation 11.4062 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | 3.234 percentage change from baseline | Standard Deviation 24.2622 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | -4.254 percentage change from baseline | Standard Deviation 17.2335 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | 15.509 percentage change from baseline | Standard Deviation 33.1029 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | 14.354 percentage change from baseline | Standard Deviation 33.2027 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | -1.748 percentage change from baseline | Standard Deviation 13.3302 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | 4.448 percentage change from baseline | Standard Deviation 18.3997 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -6.789 percentage change from baseline | Standard Deviation 9.8119 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | 9.131 percentage change from baseline | Standard Deviation 14.1892 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 8.577 percentage change from baseline | Standard Deviation 13.4307 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | -3.596 percentage change from baseline | Standard Deviation 12.5937 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 8.608 percentage change from baseline | Standard Deviation 11.9505 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -11.284 percentage change from baseline | Standard Deviation 10.8652 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | 17.712 percentage change from baseline | Standard Deviation 10.5885 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -1.807 percentage change from baseline | Standard Deviation 13.4761 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 6.474 percentage change from baseline | Standard Deviation 20.9251 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | -3.162 percentage change from baseline | Standard Deviation 56.6723 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -1.247 percentage change from baseline | Standard Deviation 19.0705 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | 12.494 percentage change from baseline | Standard Deviation 12.9419 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | 0.833 percentage change from baseline | Standard Deviation 16.677 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | 2.418 percentage change from baseline | Standard Deviation 31.5323 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | 12.259 percentage change from baseline | Standard Deviation 18.8943 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | 6.389 percentage change from baseline | Standard Deviation 13.9819 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | 7.293 percentage change from baseline | Standard Deviation 24.6717 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 18.005 percentage change from baseline | Standard Deviation 18.1277 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | 15.841 percentage change from baseline | Standard Deviation 23.4485 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | 14.111 percentage change from baseline | Standard Deviation 23.1987 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | 18.665 percentage change from baseline | Standard Deviation 28.1286 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 17.300 percentage change from baseline | Standard Deviation 28.7024 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | 20.327 percentage change from baseline | Standard Deviation 24.8686 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | 10.608 percentage change from baseline | Standard Deviation 17.0266 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | 3.576 percentage change from baseline | Standard Deviation 15.1739 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | 19.637 percentage change from baseline | Standard Deviation 13.954 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 25.846 percentage change from baseline | Standard Deviation 41.5938 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | 13.956 percentage change from baseline | Standard Deviation 19.3949 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | 20.932 percentage change from baseline | Standard Deviation 22.004 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | 33.244 percentage change from baseline | Standard Deviation 19.953 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | 2.337 percentage change from baseline | Standard Deviation 24.1029 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | 26.179 percentage change from baseline | Standard Deviation 24.2615 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -3.399 percentage change from baseline | Standard Deviation 21.0488 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | 0.893 percentage change from baseline | Standard Deviation 28.3001 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 5.471 percentage change from baseline | Standard Deviation 6.9326 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 3.453 percentage change from baseline | Standard Deviation 23.328 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -13.589 percentage change from baseline | Standard Deviation 37.8165 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | 11.789 percentage change from baseline | Standard Deviation 26.3816 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | 7.721 percentage change from baseline | Standard Deviation 39.302 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | 25.679 percentage change from baseline | Standard Deviation 36.1569 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | 25.024 percentage change from baseline | Standard Deviation 33.4126 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | 12.477 percentage change from baseline | Standard Deviation 31.9743 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | -0.774 percentage change from baseline | Standard Deviation 42.0609 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -4.220 percentage change from baseline | Standard Deviation 39.6859 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | -2.630 percentage change from baseline | Standard Deviation 42.6402 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | 13.512 percentage change from baseline | Standard Deviation 32.4953 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | 7.108 percentage change from baseline | Standard Deviation 37.6896 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | 11.095 percentage change from baseline | Standard Deviation 32.3792 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | 1.645 percentage change from baseline | Standard Deviation 27.2237 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | 4.121 percentage change from baseline | Standard Deviation 20.9339 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 16.222 percentage change from baseline | Standard Deviation 23.3731 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | 8.340 percentage change from baseline | Standard Deviation 33.133 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -1.536 percentage change from baseline | Standard Deviation 27.2663 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | 20.849 percentage change from baseline | Standard Deviation 62.3389 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -17.954 percentage change from baseline | Standard Deviation 36.9722 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | -7.186 percentage change from baseline | Standard Deviation 12.991 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | 0.979 percentage change from baseline | Standard Deviation 26.2735 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | -3.981 percentage change from baseline | Standard Deviation 20.5915 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 0.658 percentage change from baseline | Standard Deviation 22.0426 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | -1.915 percentage change from baseline | Standard Deviation 20.7555 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | 13.921 percentage change from baseline | Standard Deviation 27.0459 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | 18.209 percentage change from baseline | Standard Deviation 38.3564 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | -5.121 percentage change from baseline | Standard Deviation 13.1626 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | -25.654 percentage change from baseline | Standard Deviation 35.735 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -1.659 percentage change from baseline | Standard Deviation 19.1445 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | -3.770 percentage change from baseline | Standard Deviation 12.937 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 85 | 1.615 percentage change from baseline | Standard Deviation 20.901 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 36 | 6.048 percentage change from baseline | Standard Deviation 31.9348 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 8 | 5.801 percentage change from baseline | Standard Deviation 19.8534 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 57 | -0.175 percentage change from baseline | Standard Deviation 24.4156 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 29 | 5.779 percentage change from baseline | Standard Deviation 27.511 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 4 | 4.847 percentage change from baseline | Standard Deviation 22.2872 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 2 | -7.860 percentage change from baseline | Standard Deviation 16.6291 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 43 | 0.609 percentage change from baseline | Standard Deviation 20.9022 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 22 | 7.018 percentage change from baseline | Standard Deviation 36.6005 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 5 | 7.604 percentage change from baseline | Standard Deviation 18.377 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 3 | -4.200 percentage change from baseline | Standard Deviation 29.1776 |
| Placebo | Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time | Day 15 | -11.942 percentage change from baseline | Standard Deviation 13.2393 |
Secondary
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Time frame: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | 4.252 percentage change | Standard Deviation 5.9602 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | 8.822 percentage change | Standard Deviation 22.589 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | 6.641 percentage change | Standard Deviation 18.8735 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | 6.934 percentage change | Standard Deviation 12.8116 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | 4.801 percentage change | Standard Deviation 15.6593 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 6.087 percentage change | Standard Deviation 10.9388 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 14.208 percentage change | Standard Deviation 21.3667 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 11.576 percentage change | Standard Deviation 9.6497 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 13.219 percentage change | Standard Deviation 12.8986 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 4.055 percentage change | Standard Deviation 17.6355 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | 5.766 percentage change | Standard Deviation 12.8626 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | 5.734 percentage change | Standard Deviation 14.0949 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 8.222 percentage change | Standard Deviation 8.0005 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 5.755 percentage change | Standard Deviation 8.6481 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 5.871 percentage change | Standard Deviation 10.3258 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | -7.261 percentage change | Standard Deviation 8.1118 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | -2.471 percentage change | Standard Deviation 10.0364 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | 2.092 percentage change | Standard Deviation 13.5746 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | 5.128 percentage change | Standard Deviation 10.0036 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | 4.175 percentage change | Standard Deviation 9.7966 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | 2.271 percentage change | Standard Deviation 9.4185 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | 1.688 percentage change | Standard Deviation 11.178 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 9.358 percentage change | Standard Deviation 5.7878 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 3.056 percentage change | Standard Deviation 15.108 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | 3.026 percentage change | Standard Deviation 6.6556 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | 1.586 percentage change | Standard Deviation 10.7697 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 8.185 percentage change | Standard Deviation 13.8026 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 18.627 percentage change | Standard Deviation 11.5843 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | 4.798 percentage change | Standard Deviation 8.2785 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | 11.110 percentage change | Standard Deviation 6.1704 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 29.785 percentage change | Standard Deviation 19.503 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 20.845 percentage change | Standard Deviation 19.4756 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | 10.000 percentage change | Standard Deviation 11.8129 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | 30.350 percentage change | Standard Deviation 24.3439 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 12.216 percentage change | Standard Deviation 14.1642 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | 15.296 percentage change | Standard Deviation 36.6778 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 3.429 percentage change | Standard Deviation 12.8258 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 1.975 percentage change | Standard Deviation 15.1871 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 6.917 percentage change | Standard Deviation 16.2552 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | 7.592 percentage change | Standard Deviation 12.0591 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | -9.431 percentage change | Standard Deviation 15.5609 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | 0.230 percentage change | Standard Deviation 8.3494 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | 6.667 percentage change | Standard Deviation 15.637 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | -0.209 percentage change | Standard Deviation 5.4522 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | 0.635 percentage change | Standard Deviation 10.1481 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 4.503 percentage change | Standard Deviation 9.3465 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 10.099 percentage change | Standard Deviation 10.8958 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | -2.724 percentage change | Standard Deviation 8.4175 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 1.437 percentage change | Standard Deviation 6.4453 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | 3.157 percentage change | Standard Deviation 6.2435 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | 0.663 percentage change | Standard Deviation 8.3158 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | 3.189 percentage change | Standard Deviation 12.2261 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | 6.756 percentage change | Standard Deviation 6.3289 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | -1.473 percentage change | Standard Deviation 7.9618 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 4.501 percentage change | Standard Deviation 7.0609 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 5.338 percentage change | Standard Deviation 7.8661 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 2.365 percentage change | Standard Deviation 5.0844 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 8.281 percentage change | Standard Deviation 12.6603 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | 7.814 percentage change | Standard Deviation 19.6299 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | 2.338 percentage change | Standard Deviation 18.2941 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | -3.261 percentage change | Standard Deviation 14.2519 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 3.062 percentage change | Standard Deviation 10.489 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | -0.848 percentage change | Standard Deviation 16.4937 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 7.902 percentage change | Standard Deviation 9.1879 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | 0.554 percentage change | Standard Deviation 12.1071 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | -3.711 percentage change | Standard Deviation 9.152 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 9.743 percentage change | Standard Deviation 16.1027 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | 4.143 percentage change | Standard Deviation 16.5179 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | -3.061 percentage change | Standard Deviation 12.9637 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 8.089 percentage change | Standard Deviation 14.6337 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 3.025 percentage change | Standard Deviation 11.8149 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | 12.055 percentage change | Standard Deviation 27.4156 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 0.989 percentage change | Standard Deviation 10.4834 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 2.127 percentage change | Standard Deviation 8.3314 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | 2.020 percentage change | Standard Deviation 8.1968 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 4.071 percentage change | Standard Deviation 8.5288 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | -3.098 percentage change | Standard Deviation 11.1147 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 4.218 percentage change | Standard Deviation 6.6123 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | -0.178 percentage change | Standard Deviation 14.0562 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | -2.414 percentage change | Standard Deviation 17.1454 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | -0.711 percentage change | Standard Deviation 11.7627 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | -10.946 percentage change | Standard Deviation 16.5586 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | -7.423 percentage change | Standard Deviation 21.8432 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 1.945 percentage change | Standard Deviation 5.9013 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 8 | 0.468 percentage change | Standard Deviation 9.2202 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 36 | 1.356 percentage change | Standard Deviation 13.0154 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 22 | 5.407 percentage change | Standard Deviation 9.6448 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 57 | 1.672 percentage change | Standard Deviation 12.3701 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 15 | 3.223 percentage change | Standard Deviation 10.0156 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 4 | 2.626 percentage change | Standard Deviation 9.7866 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 85 | 1.329 percentage change | Standard Deviation 14.3518 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 43 | 1.908 percentage change | Standard Deviation 17.3185 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 29 | 3.921 percentage change | Standard Deviation 12.1504 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 5 | 1.747 percentage change | Standard Deviation 9.4714 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 3 | 3.742 percentage change | Standard Deviation 8.6378 |
| Placebo | Mean Percentage Change From Baseline in Serum Osteocalcin Over Time | Day 2 | 1.936 percentage change | Standard Deviation 9.1701 |
Secondary
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Time frame: Baseline (Days -1, 1), Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85
Population: Pharmacodynamic (PD) Analysis Population: all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter in at least 1 treatment period; number analyzed=number of participants with an observation at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 2.579 percentage change from baseline | Standard Deviation 16.2957 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | 0.105 percentage change from baseline | Standard Deviation 26.5164 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 5.155 percentage change from baseline | Standard Deviation 14.1736 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 12.199 percentage change from baseline | Standard Deviation 20.7265 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 0.161 percentage change from baseline | Standard Deviation 6.9455 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 8.524 percentage change from baseline | Standard Deviation 8.3551 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | 2.361 percentage change from baseline | Standard Deviation 16.5524 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 7.908 percentage change from baseline | Standard Deviation 10.3904 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | -3.344 percentage change from baseline | Standard Deviation 17.0168 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | -7.489 percentage change from baseline | Standard Deviation 9.5892 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | -1.986 percentage change from baseline | Standard Deviation 15.4137 |
| PF-04840082 0.3 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | 8.794 percentage change from baseline | Standard Deviation 15.6171 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 10.321 percentage change from baseline | Standard Deviation 10.8772 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 5.117 percentage change from baseline | Standard Deviation 9.1142 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | -2.352 percentage change from baseline | Standard Deviation 10.5552 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | -4.566 percentage change from baseline | Standard Deviation 5.8947 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | -17.799 percentage change from baseline | Standard Deviation 44.2793 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | 5.225 percentage change from baseline | Standard Deviation 14.3348 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 3.745 percentage change from baseline | Standard Deviation 8.0952 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 13.737 percentage change from baseline | Standard Deviation 10.2997 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 12.822 percentage change from baseline | Standard Deviation 9.7902 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 7.618 percentage change from baseline | Standard Deviation 17.3215 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | -2.066 percentage change from baseline | Standard Deviation 6.7705 |
| PF-04840082 1.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 2.836 percentage change from baseline | Standard Deviation 6.4467 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 21.394 percentage change from baseline | Standard Deviation 20.6158 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | 19.420 percentage change from baseline | Standard Deviation 42.2273 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | 27.459 percentage change from baseline | Standard Deviation 60.2028 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 10.157 percentage change from baseline | Standard Deviation 11.1075 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | 13.967 percentage change from baseline | Standard Deviation 17.9202 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | 37.825 percentage change from baseline | Standard Deviation 35.272 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | 7.884 percentage change from baseline | Standard Deviation 26.1801 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 11.237 percentage change from baseline | Standard Deviation 16.8782 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 28.710 percentage change from baseline | Standard Deviation 33.239 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 36.693 percentage change from baseline | Standard Deviation 29.184 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 23.742 percentage change from baseline | Standard Deviation 18.7153 |
| PF-04840082 6.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 32.558 percentage change from baseline | Standard Deviation 50.4404 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 5.894 percentage change from baseline | Standard Deviation 10.8227 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | 0.720 percentage change from baseline | Standard Deviation 9.327 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | 4.075 percentage change from baseline | Standard Deviation 5.5816 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 8.461 percentage change from baseline | Standard Deviation 13.9663 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 16.135 percentage change from baseline | Standard Deviation 13.1185 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 13.739 percentage change from baseline | Standard Deviation 13.9117 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | 5.423 percentage change from baseline | Standard Deviation 17.8942 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 7.649 percentage change from baseline | Standard Deviation 18.214 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 0.617 percentage change from baseline | Standard Deviation 8.3882 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 12.031 percentage change from baseline | Standard Deviation 14.0186 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | 5.535 percentage change from baseline | Standard Deviation 9.2328 |
| PF-04840082 24.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | -6.992 percentage change from baseline | Standard Deviation 20.668 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | 5.244 percentage change from baseline | Standard Deviation 8.4819 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 10.897 percentage change from baseline | Standard Deviation 20.3196 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 25.180 percentage change from baseline | Standard Deviation 18.4425 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 9.904 percentage change from baseline | Standard Deviation 13.0457 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 2.366 percentage change from baseline | Standard Deviation 5.9293 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 10.031 percentage change from baseline | Standard Deviation 9.2134 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 24.114 percentage change from baseline | Standard Deviation 20.7782 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | 23.830 percentage change from baseline | Standard Deviation 28.0126 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | 22.304 percentage change from baseline | Standard Deviation 29.7686 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 26.118 percentage change from baseline | Standard Deviation 22.8948 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | 28.914 percentage change from baseline | Standard Deviation 27.3598 |
| PF-04840082 3.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | 12.242 percentage change from baseline | Standard Deviation 14.1055 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | 1.623 percentage change from baseline | Standard Deviation 19.8165 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 7.855 percentage change from baseline | Standard Deviation 11.699 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | 3.903 percentage change from baseline | Standard Deviation 11.3291 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 12.405 percentage change from baseline | Standard Deviation 15.4178 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 7.777 percentage change from baseline | Standard Deviation 16.0762 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | 3.594 percentage change from baseline | Standard Deviation 23.5914 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 15.259 percentage change from baseline | Standard Deviation 12.37 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 11.211 percentage change from baseline | Standard Deviation 13.9796 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 2.238 percentage change from baseline | Standard Deviation 9.8233 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | 5.619 percentage change from baseline | Standard Deviation 12.2245 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 11.711 percentage change from baseline | Standard Deviation 18.7964 |
| PF-04840082 12.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | 10.576 percentage change from baseline | Standard Deviation 15.4128 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | -9.057 percentage change from baseline | Standard Deviation 18.0136 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | -1.626 percentage change from baseline | Standard Deviation 11.2516 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | -3.213 percentage change from baseline | Standard Deviation 18.3073 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | 10.753 percentage change from baseline | Standard Deviation 16.1139 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | -12.708 percentage change from baseline | Standard Deviation 17.094 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | 6.055 percentage change from baseline | Standard Deviation 12.4378 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | 9.717 percentage change from baseline | Standard Deviation 18.53 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | 11.284 percentage change from baseline | Standard Deviation 13.1751 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 13.370 percentage change from baseline | Standard Deviation 17.6498 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | 12.696 percentage change from baseline | Standard Deviation 19.6629 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | 4.568 percentage change from baseline | Standard Deviation 21.1743 |
| PF-04840082 18.0 mg/kg | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | -2.263 percentage change from baseline | Standard Deviation 22.4866 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 22 | -0.132 percentage change from baseline | Standard Deviation 9.1245 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 15 | -0.968 percentage change from baseline | Standard Deviation 14.1064 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 85 | 0.820 percentage change from baseline | Standard Deviation 14.4801 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 57 | -2.427 percentage change from baseline | Standard Deviation 12.3301 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 8 | -0.979 percentage change from baseline | Standard Deviation 9.7628 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 5 | -3.344 percentage change from baseline | Standard Deviation 12.6299 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 4 | -4.193 percentage change from baseline | Standard Deviation 9.1093 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 3 | 4.963 percentage change from baseline | Standard Deviation 8.9468 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 2 | 3.005 percentage change from baseline | Standard Deviation 6.4941 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 29 | -6.509 percentage change from baseline | Standard Deviation 24.9432 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 43 | 1.210 percentage change from baseline | Standard Deviation 17.0653 |
| Placebo | Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time | Day 36 | 1.941 percentage change from baseline | Standard Deviation 12.6475 |
Secondary
Percentage Change From Baseline in Total Dickkopf-1 (DKK-1) Concentrations Over Time
Time frame: Day -1, Day 1 (predose and at end of infusion) and at 2, 4, 8, and 12 hours postdose, and Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57, and 85
Population: Pharmacodynamic (PD) Analysis Population: all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter in at least 1 treatment period. Analytical qualification of a total DKK-1 assay was unsuccessful, thus no data was collected and reported.
Secondary
PK/PD Model Describing the Relationship Between PF-04840082 PK Parameter Estimates/Concentrations and Changes in PD Endpoints
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time frame: Day 1 to Day 85
Secondary
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Terminal Elimination Half-Life (t1/2) | NA hours | — |
| PF-04840082 1.0 mg/kg | Terminal Elimination Half-Life (t1/2) | 358.7 hours | Standard Deviation 50.603 |
| PF-04840082 6.0 mg/kg | Terminal Elimination Half-Life (t1/2) | 637.8 hours | Standard Deviation 110.06 |
| PF-04840082 24.0 mg/kg | Terminal Elimination Half-Life (t1/2) | NA hours | — |
| PF-04840082 3.0 mg/kg | Terminal Elimination Half-Life (t1/2) | 486.9 hours | Standard Deviation 92.644 |
| PF-04840082 12.0 mg/kg | Terminal Elimination Half-Life (t1/2) | 657.5 hours | Standard Deviation 88.686 |
| PF-04840082 18.0 mg/kg | Terminal Elimination Half-Life (t1/2) | 829.0 hours | Standard Deviation 82.286 |
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04840082 0.3 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 1.49 hours |
| PF-04840082 1.0 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.05 hours |
| PF-04840082 6.0 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.00 hours |
| PF-04840082 24.0 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.00 hours |
| PF-04840082 3.0 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 1.56 hours |
| PF-04840082 12.0 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.00 hours |
| PF-04840082 18.0 mg/kg | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.00 hours |
Secondary
Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion
Population: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, overall number of participants analyzed= number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04840082 0.3 mg/kg | Volume of Distribution at Steady State (Vss) | NA mL | — |
| PF-04840082 1.0 mg/kg | Volume of Distribution at Steady State (Vss) | 3817 mL | Standard Deviation 601.08 |
| PF-04840082 6.0 mg/kg | Volume of Distribution at Steady State (Vss) | 3511 mL | Standard Deviation 517.52 |
| PF-04840082 24.0 mg/kg | Volume of Distribution at Steady State (Vss) | NA mL | — |
| PF-04840082 3.0 mg/kg | Volume of Distribution at Steady State (Vss) | 3822 mL | Standard Deviation 657.59 |
| PF-04840082 12.0 mg/kg | Volume of Distribution at Steady State (Vss) | 3782 mL | Standard Deviation 703.64 |
| PF-04840082 18.0 mg/kg | Volume of Distribution at Steady State (Vss) | 4063 mL | Standard Deviation 291.03 |