| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to 28 days after last dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4. |
| | Units | Counts |
|---|
| Participants | - OG00022
- OG00121
- OG00221
- OG003
|
| | Title | Denominators | Categories |
|---|
| AEs | | | Title | Measurements |
|---|
| - OG00011
- OG00115
- OG00210
- OG003
|
|
| |
| Primary | Number of Participants With Laboratory Abnormalities | Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]). | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | participants | | Baseline up to Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | |
|
| Primary | Number of Participants With Clinically Significant Vital Sign Abnormalities | Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg |
|
| Primary | Number of Participants With Clinically Significant Electrocardiogram Findings | Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | |
|
| Primary | Number of Participants With Abnormal Physical Examinations | Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system. | Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section. | Posted | | | | | | Baseline up to Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. |
|
| Primary | Thyroid Stimulating Hormone (TSH) Level at Baseline | Results are reported in micro international units per milliliter (mcIU/mL). | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | mcIU/mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Thyroid Stimulating Hormone (TSH) Level at Day 1 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mcIU/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | |
|
| Primary | Thyroid Stimulating Hormone (TSH) Level at Day 25 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mcIU/mL | | Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | |
|
| Primary | Thyroid Stimulating Hormone (TSH) Level at Day 39 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mcIU/mL | | Day 39 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | |
|
| Primary | Thyroid Stimulating Hormone (TSH) Level at Day 49 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mcIU/mL | | Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | |
|
| Primary | Phosphate Level at Baseline | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | milligram per deciliter (mg/dL) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | |
|
| Primary | Change From Baseline in Phosphate Level at Day 8 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | mg/dL | | Baseline, Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg | |
|
| Primary | Change From Baseline in Phosphate Level at Day 15 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | mg/dL | | Baseline, Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Phosphate Level at Day 25 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | mg/dL | | Baseline, Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Phosphate Level at Day 49 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | mg/dL | | Baseline, Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Creatine Phosphokinase (CPK) Level at Baseline | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | units per liter (U/L) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | U/L | | Baseline, Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | U/L | | Baseline, Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | U/L | | Baseline, Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | U/L | | Baseline, Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | nanogram per milliliter (NG/ML) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 39 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49 | | Safety analysis set included all participants who receive at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | microgram per liter (mcg/l) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 39 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units per liter (U/L) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 39 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 |
|
| Primary | Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | Day 49 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively. | Posted | | Mean | Standard Deviation | milligram per 24 hours (mg/24hr) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively | Posted | | Mean | Standard Deviation | mg/24 hours | | Day 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG004 | PF-05231023 150 mg |
|
| Primary | Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1 | Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative. | Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively | Posted | | Number | | participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 150 mg |
|
| Primary | Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39 | Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative. | Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for specified antibodies for each arm, respectively and "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | participants | | Day 39 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 |
|
| Primary | Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49 | | Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for specified antibodies for each arm, respectively and "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | participants | | Day 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 150 mg | PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4. |
| |
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose | AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. |
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose | Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hours | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 150 mg |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose | Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 | PF-05231023 150 mg |
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose | AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 |
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose | Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Median | Full Range | hours | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose | Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 |
|
| Secondary | Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023 | Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ratio | | 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | |
|
| Secondary | Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023 | Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ratio | | 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | |
|
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose | Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 |
|
| Secondary | Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose | Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG003 |
|
| Secondary | Plasma Decay Half-Life (t1/2) of PF-05231023 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | hours | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. | |
|
| Secondary | Apparent Clearance (CL) of PF-05231023 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure. | PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | liter/hour (L/hr) | | 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 25 mg | PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. | | OG001 | PF-05231023 50 mg | PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. |
|