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CompletedNCT01293487Updated Sep 24, 2024Results posted

Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.

A Phase 1 interventional study of RN564 in Osteopenia, Osteoporosis and Bone Disease, sponsored by Pfizer. Completed at 8 sites in United States. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
55 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.

02

Conditions studied

  • Osteopenia
  • Osteoporosis
  • Bone Disease

Keywords

  • Phase 1
  • Osteopenia
  • RN564
03

In context

Bone Diseases, Metabolic

487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.

This study's enrollment of 68 is above the median of 61 across 372 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Arm 1

    Biological: RN564

Interventions

  • BiologicalRN564

    Intravenous, single dose with experimental dose

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  7. Median Change From Baseline in Hematocrit at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  8. Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  9. 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)

  10. Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  11. 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)

  12. Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation

    Time frame: Baseline, Last observation (up to Day 85)

  13. Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation

    Time frame: Baseline, Last Observation (up to Day 85)

  14. Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  15. Median Change From Baseline in T4 at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  16. Median Change From Baseline in Urine WBC at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  17. Median Change From Baseline in Urine pH at Last Observation

    Time frame: Baseline, last observation (up to Day 85)

  18. 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

  19. 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

  20. Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit

    Time frame: Days -1, 8, 15, 29, 43, 57, and 85

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85

    Time frame: Days -1 and 85

  16. Femoral Neck BMD at Day 85

    BMD was evaluated by dual energy X-ray absorptiometry (DXA).

    Time frame: Day 85

  17. 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

  18. Mean Percentage Change From Baseline in Distal Radius BMD at Day 85

    BMD was evaluated by DXA.

    Time frame: Baseline (Day -1), Day 85

  19. 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

07

Results

Posted Sep 24, 2024

Participant flow

Participant flow — Overall Study
MilestonePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Started666688820
Completed666588818
Not completed00010002
Withdrew: Lost to follow-up00010000
Withdrew: Withdrawal by subject00000002

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)
ParticipantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)00000000
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With All-Causality AEs by Grade
percentage of participantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Grade 1100.050.0100.066.762.537.562.560.0
Grade 2016.7016.7025.012.510.0
Grade 30000012.500
Grade 400000000
Grade 500000000
Missing/Unknown00000000
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-Related AEs by Grade
percentage of participantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Grade 150.016.750.033.350.0037.520.0
Grade 2016.700012.500
Grade 300000000
Grade 400000000
Grade 500000000
Missing/Unknown00000000
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Any Laboratory Abnormality
ParticipantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Number of Participants With Any Laboratory Abnormality334134412
PrimaryMedian 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)
Reported as:
Median · 10^3 cells/millimeter cube (mm^3)
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
10^3 cells/millimeter cube (mm^3)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Platelets8 (NA to NA)-9 (NA to NA)7 (NA to NA)4 (NA to NA)-3 (NA to NA)-31 (NA to NA)-5 (NA to NA)-6 (NA to NA)
White Blood Cell Count-0.8 (NA to NA)-0.2 (NA to NA)-0.5 (NA to NA)-0.9 (NA to NA)-0.1 (NA to NA)-0.8 (NA to NA)0.0 (NA to NA)-0.4 (NA to NA)
Lymphocytes (Abs)-0.10 (NA to NA)-0.06 (NA to NA)0.06 (NA to NA)-0.06 (NA to NA)0.07 (NA to NA)-0.05 (NA to NA)0.09 (NA to NA)0.00 (NA to NA)
Total Neutrophils (Abs)-0.78 (NA to NA)0.04 (NA to NA)-0.34 (NA to NA)-0.51 (NA to NA)-0.12 (NA to NA)-0.61 (NA to NA)-0.11 (NA to NA)-0.35 (NA to NA)
Basophils (Abs)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)
Eosinophils (Abs)0.03 (NA to NA)0.00 (NA to NA)0.04 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)
Monocytes (Abs)-0.10 (NA to NA)-0.04 (NA to NA)0.00 (NA to NA)-0.04 (NA to NA)0.03 (NA to NA)-0.03 (NA to NA)0.00 (NA to NA)0.00 (NA to NA)
PrimaryMedian Change From Baseline in Red Blood Cell (RBC) Count at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · 10^6 cells/mm^3
Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation
10^6 cells/mm^3PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation-0.05 (NA to NA)-0.07 (NA to NA)-0.14 (NA to NA)-0.10 (NA to NA)0.05 (NA to NA)-0.30 (NA to NA)0.06 (NA to NA)-0.07 (NA to NA)
PrimaryMedian Change From Baseline in Hematocrit at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · percentage of red blood cells
Median Change From Baseline in Hematocrit at Last Observation
percentage of red blood cellsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Median Change From Baseline in Hematocrit at Last Observation0.6 (NA to NA)1.4 (NA to NA)-0.8 (NA to NA)-0.4 (NA to NA)1.0 (NA to NA)-2.4 (NA to NA)0.5 (NA to NA)-0.8 (NA to NA)
PrimaryMedian Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · grams/deciliter (g/dL)
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
grams/deciliter (g/dL)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Hemoglobin (HGB)-0.3 (NA to NA)-0.6 (NA to NA)-0.6 (NA to NA)-0.1 (NA to NA)-0.1 (NA to NA)-0.8 (NA to NA)-0.2 (NA to NA)-0.4 (NA to NA)
Total Protein-0.5 (NA to NA)-0.3 (NA to NA)-0.1 (NA to NA)0.1 (NA to NA)0.2 (NA to NA)-0.3 (NA to NA)-0.0 (NA to NA)-0.2 (NA to NA)
Albumin-0.3 (NA to NA)-0.2 (NA to NA)-0.0 (NA to NA)0.0 (NA to NA)0.2 (NA to NA)-0.3 (NA to NA)0.0 (NA to NA)-0.1 (NA to NA)
PrimaryMedian 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)
Reported as:
Median · milligrams/dL (mg/dL)
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
milligrams/dL (mg/dL)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Total Bilirubin-0.2 (NA to NA)-0.1 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)-0.2 (NA to NA)-0.2 (NA to NA)-0.2 (NA to NA)0.0 (NA to NA)
Direct Bilirubin0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)
Indirect Bilirubin-0.2 (NA to NA)-0.1 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)-0.1 (NA to NA)-0.2 (NA to NA)-0.2 (NA to NA)-0.0 (NA to NA)
Blood Urea Nitrogen (BUN)-4.7 (NA to NA)5.0 (NA to NA)-3.5 (NA to NA)3.8 (NA to NA)-2.1 (NA to NA)1.2 (NA to NA)1.3 (NA to NA)-0.4 (NA to NA)
Creatinine-0.1 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)0.1 (NA to NA)0.1 (NA to NA)0.0 (NA to NA)
Uric Acid-1.0 (NA to NA)-0.1 (NA to NA)-0.2 (NA to NA)-0.2 (NA to NA)-0.1 (NA to NA)1.2 (NA to NA)0.2 (NA to NA)-0.2 (NA to NA)
Calcium-0.2 (NA to NA)-0.2 (NA to NA)-0.2 (NA to NA)-0.2 (NA to NA)-0.1 (NA to NA)0.1 (NA to NA)-0.1 (NA to NA)-0.2 (NA to NA)
Magnesium-0.1 (NA to NA)-0.0 (NA to NA)0.0 (NA to NA)0.1 (NA to NA)0.0 (NA to NA)-0.1 (NA to NA)0.0 (NA to NA)0.0 (NA to NA)
Glucose-11 (NA to NA)2 (NA to NA)1 (NA to NA)3 (NA to NA)-1 (NA to NA)-11 (NA to NA)-1 (NA to NA)0 (NA to NA)
PrimaryMedian Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · milliequivalents (mEq)/liter (L)
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
milliequivalents (mEq)/liter (L)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Sodium-1 (NA to NA)-0 (NA to NA)-1 (NA to NA)-1 (NA to NA)0 (NA to NA)0 (NA to NA)-1 (NA to NA)0 (NA to NA)
Potassium0.1 (NA to NA)0.0 (NA to NA)0.1 (NA to NA)0.2 (NA to NA)0.3 (NA to NA)-0.3 (NA to NA)-0.2 (NA to NA)-0.1 (NA to NA)
Chloride-1 (NA to NA)0 (NA to NA)-1 (NA to NA)0 (NA to NA)1 (NA to NA)2 (NA to NA)-0 (NA to NA)-0 (NA to NA)
Bicarbonate (venous)0.2 (NA to NA)0.3 (NA to NA)0.6 (NA to NA)-1.5 (NA to NA)0.0 (NA to NA)-0.3 (NA to NA)-0.3 (NA to NA)0.0 (NA to NA)
PrimaryMedian 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)
Reported as:
Median · international units (IU)/L
Median Change From Baseline in Liver Function Tests at Last Observation
international units (IU)/LPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Aminotransferase (AST)-1 (NA to NA)0 (NA to NA)-2 (NA to NA)1 (NA to NA)2 (NA to NA)1 (NA to NA)-1 (NA to NA)1 (NA to NA)
Alanine Aminotransferase (ALT)0 (NA to NA)-3 (NA to NA)2 (NA to NA)-1 (NA to NA)1 (NA to NA)1 (NA to NA)-8 (NA to NA)0 (NA to NA)
Gamma GT-8 (NA to NA)-6 (NA to NA)1 (NA to NA)-2 (NA to NA)4 (NA to NA)-3 (NA to NA)3 (NA to NA)-1 (NA to NA)
Alkaline Phosphatase1 (NA to NA)-5 (NA to NA)4 (NA to NA)10 (NA to NA)7 (NA to NA)-2 (NA to NA)-5 (NA to NA)-3 (NA to NA)
PrimaryMedian Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation
Time frame:
Baseline, Last observation (up to Day 85)
Reported as:
Median · micro IU (mIU)/mL
Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation
micro IU (mIU)/mLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation0 (NA to NA)0 (NA to NA)0 (NA to NA)-0 (NA to NA)0 (NA to NA)0 (NA to NA)1 (NA to NA)0 (NA to NA)
PrimaryMedian Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Time frame:
Baseline, Last Observation (up to Day 85)
Reported as:
Median · units (U)/L
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
units (U)/LPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Creatine Kinase (CK)-17 (NA to NA)21 (NA to NA)-43 (NA to NA)13 (NA to NA)1 (NA to NA)-11 (NA to NA)4 (NA to NA)-16 (NA to NA)
Amylase5 (NA to NA)-1 (NA to NA)4 (NA to NA)1 (NA to NA)7 (NA to NA)-1 (NA to NA)-12 (NA to NA)0 (NA to NA)
Lipase-1 (NA to NA)5 (NA to NA)-8 (NA to NA)14 (NA to NA)-7 (NA to NA)-8 (NA to NA)-3 (NA to NA)4 (NA to NA)
PrimaryMedian Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · nanograms (ng)/dL
Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
nanograms (ng)/dLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
T3 (free)——-0.0 (NA to NA)—-0.0 (NA to NA)——-0.0 (NA to NA)
T4 (free)——-0.0 (NA to NA)—0.0 (NA to NA)——0.0 (NA to NA)
PrimaryMedian Change From Baseline in T4 at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · micrograms (mcg)/dL
Median Change From Baseline in T4 at Last Observation
micrograms (mcg)/dLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Median Change From Baseline in T4 at Last Observation0.3 (NA to NA)0.9 (NA to NA)-1.6 (NA to NA)0.0 (NA to NA)—-0.3 (NA to NA)0.2 (NA to NA)0.1 (NA to NA)
PrimaryMedian Change From Baseline in Urine WBC at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · /high-powered field (HPF)
Median Change From Baseline in Urine WBC at Last Observation
/high-powered field (HPF)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Median Change From Baseline in Urine WBC at Last Observation—-1.0 (NA to NA)—0.0 (NA to NA)———-1.0 (NA to NA)
PrimaryMedian Change From Baseline in Urine pH at Last Observation
Time frame:
Baseline, last observation (up to Day 85)
Reported as:
Median · pH
Median Change From Baseline in Urine pH at Last Observation
pHPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Median Change From Baseline in Urine pH at Last Observation0.3 (NA to NA)0.7 (NA to NA)0.3 (NA to NA)0.0 (NA to NA)0.6 (NA to NA)-0.3 (NA to NA)0.0 (NA to NA)0.3 (NA to NA)
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
ParticipantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
≥30 mmHg decrease from baseline in supine SBP30000303
≥30 mmHg decrease from baseline in standing SBP30001314
≥20 mmHg decrease from baseline in supine DBP10101102
≥20 mmHg decrease from baseline in standing DBP00001213
≥30 mmHg increase from baseline in supine SBP00010001
≥30 mmHg increase from baseline in standing SBP01030102
≥20 mmHg increase from baseline in supine DBP00110001
≥20 mmHg increase from baseline in standing DBP00111100
PrimaryNumber 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
Reported as:
Number · participants
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
participantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
≥25/50% increase from BSL in PR interval00000000
≥25/50% increase from BSL in QRS complex00000000
≥30 to <60 msec increase from BSL in QTc interval10000000
≥60 msec increase from BSL in QTc interval00000000
≥30 to <60 msec increase from BSL in QTcF interval20101101
≥60 msec increase from BSL in QTcF interval00000001
PrimaryNumber of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Time frame:
Days -1, 8, 15, 29, 43, 57, and 85
Reported as:
Number · Participants
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
ParticipantsPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Day -11000000
Day 81100000
Day 151100100
Day 291100000
Day 431100000
Day 571100000
Day 851100000
SecondaryArea 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
Reported as:
Geometric mean · mcg*h/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
mcg*h/mLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)1175 ± 197.797588 ± 1297.186360 ± 12846348800 ± 4323033960 ± 4326.5171100 ± 12762269600 ± 27289
SecondaryMaximum 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
Reported as:
Geometric mean · mcg/mL
Maximum Observed Serum Concentration (Cmax)
mcg/mLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Maximum Observed Serum Concentration (Cmax)9.580 ± 0.6954529.20 ± 4.3353205.8 ± 29.743687.3 ± 69.03292.05 ± 27.124409.6 ± 56.592549.4 ± 60.738
SecondaryTime 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
Reported as:
Median · hours
Time to Reach Maximum Observed Serum Concentration (Tmax)
hoursPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Time to Reach Maximum Observed Serum Concentration (Tmax)1.49 (1.00 to 4.00)2.05 (2.00 to 4.00)2.00 (1.12 to 4.00)2.00 (1.02 to 8.00)1.56 (1.08 to 72.0)2.00 (1.00 to 4.00)2.00 (2.00 to 4.03)
SecondaryVolume 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
Reported as:
Geometric mean · mL
Volume of Distribution at Steady State (Vss)
mLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Volume of Distribution at Steady State (Vss)NA ± NA3817 ± 601.083511 ± 517.52NA ± NA3822 ± 657.593782 ± 703.644063 ± 291.03
SecondaryClearance (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
Reported as:
Geometric mean · mL/hr
Clearance (CL)
mL/hrPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Clearance (CL)—7.647 ± 1.98044.011 ± 0.72503—5.729 ± 1.23994.248 ± 0.774453.587 ± 0.32146
SecondaryTerminal 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
Reported as:
Mean · hours
Terminal Elimination Half-Life (t1/2)
hoursPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Terminal Elimination Half-Life (t1/2)NA ± NA358.7 ± 50.603637.8 ± 110.06NA ± NA486.9 ± 92.644657.5 ± 88.686829.0 ± 82.286
SecondaryArea 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
Reported as:
Geometric mean · mcg*h/mL
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
mcg*h/mLPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kg
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]NA ± NA8655 ± 1390.497010 ± 18085NA ± NA36270 ± 5387.0192600 ± 13512323800 ± 34395
SecondaryApparent 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

No measurements were reported for this outcome.

SecondaryPercentage 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

No measurements were reported for this outcome.

SecondaryMean 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
Reported as:
Mean · percentage change from baseline
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
percentage change from baselinePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Day 20.161 ± 6.94552.836 ± 6.446711.237 ± 16.87825.894 ± 10.82272.366 ± 5.92932.238 ± 9.8233-1.626 ± 11.25163.005 ± 6.4941
Day 37.908 ± 10.39043.745 ± 8.095210.157 ± 11.10758.461 ± 13.966310.031 ± 9.213411.711 ± 18.7964-3.213 ± 18.30734.963 ± 8.9468
Day 42.361 ± 16.5524-2.066 ± 6.770513.967 ± 17.92024.075 ± 5.58165.244 ± 8.48193.903 ± 11.3291-9.057 ± 18.0136-4.193 ± 9.1093
Day 58.794 ± 15.6171-2.352 ± 10.55527.884 ± 26.18015.535 ± 9.232812.242 ± 14.10555.619 ± 12.2245-12.708 ± 17.0940-3.344 ± 12.6299
Day 812.199 ± 20.726510.321 ± 10.877221.394 ± 20.61580.617 ± 8.388210.897 ± 20.31967.777 ± 16.07626.055 ± 12.4378-0.979 ± 9.7628
Day 158.524 ± 8.35517.618 ± 17.321528.710 ± 33.239012.031 ± 14.01869.904 ± 13.045715.259 ± 12.37009.717 ± 18.5300-0.968 ± 14.1064
Day 225.155 ± 14.173612.822 ± 9.790236.693 ± 29.184013.739 ± 13.911724.114 ± 20.778211.211 ± 13.979611.284 ± 13.1751-0.132 ± 9.1245
Day 292.579 ± 16.29575.117 ± 9.114223.742 ± 18.715316.135 ± 13.118526.118 ± 22.894812.405 ± 15.417810.753 ± 16.1139-6.509 ± 24.9432
Day 36-3.344 ± 17.016813.737 ± 10.299732.558 ± 50.44047.649 ± 18.214025.180 ± 18.44257.855 ± 11.699013.370 ± 17.64981.941 ± 12.6475
Day 43-1.986 ± 15.4137-17.799 ± 44.279319.420 ± 42.22730.720 ± 9.327028.914 ± 27.359810.576 ± 15.412812.696 ± 19.66291.210 ± 17.0653
Day 570.105 ± 26.51645.225 ± 14.334827.459 ± 60.2028-6.992 ± 20.668023.830 ± 28.01263.594 ± 23.59144.568 ± 21.1743-2.427 ± 12.3301
Day 85-7.489 ± 9.5892-4.566 ± 5.894737.825 ± 35.27205.423 ± 17.894222.304 ± 29.76861.623 ± 19.8165-2.263 ± 22.48660.820 ± 14.4801
SecondaryMean 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
Reported as:
Mean · percentage change from baseline
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
percentage change from baselinePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Day 2-4.602 ± 14.2023-6.789 ± 9.8119-1.247 ± 19.070519.637 ± 13.9540-3.399 ± 21.0488-4.220 ± 39.6859-1.659 ± 19.1445-7.860 ± 16.6291
Day 3-17.167 ± 5.7802-1.748 ± 13.33022.418 ± 31.532313.956 ± 19.39490.893 ± 28.30014.121 ± 20.933918.209 ± 38.3564-4.200 ± 29.1776
Day 4-9.634 ± 9.59234.448 ± 18.39977.293 ± 24.671715.841 ± 23.44852.337 ± 24.1029-0.774 ± 42.060913.921 ± 27.04594.847 ± 22.2872
Day 52.826 ± 11.40628.577 ± 13.430718.005 ± 18.127717.300 ± 28.70245.471 ± 6.9326-2.630 ± 42.64020.658 ± 22.04267.604 ± 18.3770
Day 85.301 ± 9.81208.608 ± 11.95056.474 ± 20.925125.846 ± 41.59383.453 ± 23.328016.222 ± 23.3731-7.186 ± 12.99105.801 ± 19.8534
Day 15-7.765 ± 4.8847-11.284 ± 10.8652-1.807 ± 13.476110.608 ± 17.0266-13.589 ± 37.8165-1.536 ± 27.2663-17.954 ± 36.9722-11.942 ± 13.2393
Day 22-0.445 ± 22.340415.509 ± 33.10296.389 ± 13.981918.665 ± 28.128611.789 ± 26.38161.645 ± 27.2237-3.770 ± 12.93707.018 ± 36.6005
Day 29-0.026 ± 19.4086-4.254 ± 17.233517.712 ± 10.588533.244 ± 19.95307.721 ± 39.302011.095 ± 32.37920.979 ± 26.27355.779 ± 27.5110
Day 36-3.067 ± 17.77543.234 ± 24.262212.494 ± 12.94193.576 ± 15.173926.179 ± 24.26158.340 ± 33.1330-3.981 ± 20.59156.048 ± 31.9348
Day 43-7.690 ± 21.3058-3.596 ± 12.59370.833 ± 16.677014.111 ± 23.198725.679 ± 36.156913.512 ± 32.4953-1.915 ± 20.75550.609 ± 20.9022
Day 572.287 ± 20.63259.131 ± 14.189212.259 ± 18.894320.932 ± 22.004025.024 ± 33.412620.849 ± 62.3389-25.654 ± 35.7350-0.175 ± 24.4156
Day 855.677 ± 6.573814.354 ± 33.2027-3.162 ± 56.672320.327 ± 24.868612.477 ± 31.97437.108 ± 37.6896-5.121 ± 13.16261.615 ± 20.9010
SecondaryMean 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
Reported as:
Mean · percentage change
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
percentage changePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Day 23.467 ± 7.65286.218 ± 19.649226.444 ± 16.59919.644 ± 6.91920.024 ± 14.14434.756 ± 16.32687.585 ± 8.76742.372 ± 27.8091
Day 3-4.472 ± 7.90834.296 ± 15.110516.416 ± 6.251711.628 ± 9.2015-0.980 ± 17.34306.211 ± 24.104014.878 ± 17.61799.334 ± 15.7981
Day 4-10.411 ± 13.51451.482 ± 14.904215.999 ± 18.0461-0.529 ± 14.2914-5.354 ± 25.1017-14.378 ± 12.34893.407 ± 20.99377.499 ± 15.6537
Day 5-8.039 ± 9.85368.380 ± 20.40099.864 ± 20.1860-0.322 ± 8.06550.462 ± 27.4688-6.551 ± 16.739711.802 ± 25.15673.983 ± 20.4928
Day 8-9.424 ± 10.3618-8.866 ± 19.86828.572 ± 24.7327-6.834 ± 9.6209-8.233 ± 31.2067-5.499 ± 21.6249-6.296 ± 17.18321.488 ± 15.6940
Day 15-12.864 ± 9.2562-7.907 ± 8.507724.010 ± 20.2593-2.931 ± 10.3678-12.009 ± 14.0871-4.800 ± 14.0773-4.586 ± 19.84017.668 ± 19.2344
Day 22-9.972 ± 14.6179-8.980 ± 16.177625.799 ± 20.0022-17.477 ± 9.9364-10.414 ± 10.1372-12.078 ± 17.7073-4.843 ± 14.479112.395 ± 42.6940
Day 29-6.741 ± 8.4135-11.367 ± 8.067327.694 ± 23.72591.130 ± 15.5004-19.376 ± 15.1382-3.761 ± 17.8403-5.356 ± 22.74102.626 ± 16.7445
Day 364.934 ± 19.2980-14.092 ± 14.600626.589 ± 18.1507-9.145 ± 22.6658-13.549 ± 16.1342-6.819 ± 30.20602.090 ± 15.88851.337 ± 21.1947
Day 43-9.903 ± 18.88290.422 ± 11.885618.554 ± 33.9325-8.871 ± 19.2661-1.681 ± 19.1395-8.608 ± 17.65585.776 ± 12.92041.531 ± 14.7672
Day 571.090 ± 16.2461-1.360 ± 11.708113.993 ± 17.1176-13.721 ± 13.00903.519 ± 29.4764-7.134 ± 28.0770-10.254 ± 16.10502.932 ± 23.9281
Day 85-5.989 ± 16.6472-5.584 ± 19.422333.724 ± 44.0981-14.097 ± 18.5865-4.368 ± 22.8715-12.647 ± 15.1312-9.104 ± 18.49642.521 ± 18.3823
SecondaryMean 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
Reported as:
Mean · percentage change
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
percentage changePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Day 2-6.185 ± 6.3059-2.849 ± 3.8567-0.796 ± 7.4823-7.570 ± 9.2328-0.796 ± 3.6143-6.334 ± 7.9459-3.927 ± 5.4622-3.934 ± 7.4244
Day 3-4.280 ± 9.53830.331 ± 6.44244.848 ± 10.65910.125 ± 7.85410.160 ± 7.3513-7.289 ± 5.5333-4.873 ± 14.7151-3.010 ± 8.1557
Day 40.929 ± 8.44490.729 ± 5.93555.189 ± 8.73652.074 ± 9.40772.460 ± 5.91790.052 ± 6.5211-2.325 ± 16.0997-0.876 ± 7.4064
Day 51.621 ± 11.32102.592 ± 6.47591.767 ± 8.06760.313 ± 3.97810.038 ± 5.5704-2.158 ± 10.6419-4.115 ± 16.0237-0.124 ± 10.4404
Day 86.038 ± 4.87267.438 ± 7.89486.823 ± 9.14495.260 ± 9.70940.558 ± 8.74572.468 ± 12.5723-0.332 ± 13.5092-0.594 ± 10.8209
Day 1511.455 ± 7.67606.526 ± 6.57556.179 ± 9.102710.983 ± 10.90693.291 ± 9.49294.573 ± 9.07420.048 ± 8.8057-5.780 ± 12.2364
Day 2219.200 ± 6.809515.884 ± 17.18664.513 ± 12.98149.570 ± 11.16033.469 ± 15.0685-2.533 ± 7.48532.937 ± 13.2892-2.589 ± 14.3755
Day 2917.180 ± 7.204717.688 ± 18.62774.684 ± 14.001013.649 ± 7.9592-1.368 ± 16.3976-0.313 ± 14.45153.230 ± 16.5615-4.472 ± 15.3127
Day 3612.815 ± 7.198610.798 ± 16.46329.205 ± 15.81639.652 ± 6.55967.952 ± 10.8748-0.917 ± 14.92141.002 ± 12.9844-0.863 ± 13.2753
Day 433.622 ± 5.826311.610 ± 14.587110.813 ± 12.74249.018 ± 8.06718.902 ± 16.70390.731 ± 11.65165.795 ± 15.45800.977 ± 13.0563
Day 576.766 ± 4.25350.848 ± 15.58897.169 ± 19.21220.851 ± 18.54199.197 ± 19.9274-10.431 ± 14.35420.676 ± 16.38640.155 ± 11.9164
Day 858.418 ± 9.2449-0.234 ± 8.35307.156 ± 8.60108.344 ± 5.440113.720 ± 17.5660-5.825 ± 16.87647.332 ± 12.05813.076 ± 13.2167
SecondaryMean 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
Reported as:
Mean · percentage change
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
percentage changePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Day 25.734 ± 14.09491.688 ± 11.17804.798 ± 8.27850.635 ± 10.14810.663 ± 8.3158-3.061 ± 12.9637-10.946 ± 16.55861.936 ± 9.1701
Day 34.252 ± 5.9602-2.471 ± 10.03643.026 ± 6.6556-0.209 ± 5.45223.157 ± 6.2435-3.711 ± 9.1520-7.423 ± 21.84323.742 ± 8.6378
Day 44.801 ± 15.65932.092 ± 13.574610.000 ± 11.81290.230 ± 8.34943.189 ± 12.2261-3.261 ± 14.2519-0.178 ± 14.05622.626 ± 9.7866
Day 56.641 ± 18.87354.175 ± 9.79661.586 ± 10.76977.592 ± 12.05916.756 ± 6.3289-0.848 ± 16.4937-3.098 ± 11.11471.747 ± 9.4714
Day 88.822 ± 22.58902.271 ± 9.418511.110 ± 6.1704-2.724 ± 8.4175-1.473 ± 7.96184.143 ± 16.51792.020 ± 8.19680.468 ± 9.2202
Day 154.055 ± 17.63553.056 ± 15.108012.216 ± 14.16421.975 ± 15.18714.501 ± 7.06093.062 ± 10.48900.989 ± 10.48343.223 ± 10.0156
Day 2213.219 ± 12.89865.755 ± 8.648129.785 ± 19.50304.503 ± 9.34655.338 ± 7.86613.025 ± 11.81491.945 ± 5.90135.407 ± 9.6448
Day 2911.576 ± 9.64975.871 ± 10.325818.627 ± 11.584310.099 ± 10.89581.437 ± 6.44539.743 ± 16.10272.127 ± 8.33143.921 ± 12.1504
Day 3614.208 ± 21.36679.358 ± 5.787820.845 ± 19.47566.917 ± 16.25522.365 ± 5.08448.089 ± 14.63374.071 ± 8.52881.356 ± 13.0154
Day 436.087 ± 10.93888.222 ± 8.00058.185 ± 13.80263.429 ± 12.82588.281 ± 12.66037.902 ± 9.18794.218 ± 6.61231.908 ± 17.3185
Day 576.934 ± 12.81165.128 ± 10.003615.296 ± 36.6778-9.431 ± 15.56097.814 ± 19.629912.055 ± 27.4156-0.711 ± 11.76271.672 ± 12.3701
Day 855.766 ± 12.8626-7.261 ± 8.111830.350 ± 24.34396.667 ± 15.63702.338 ± 18.29410.554 ± 12.1071-2.414 ± 17.14541.329 ± 14.3518
SecondaryMean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
Time frame:
Days -1 and 85
Reported as:
Mean · percentage change
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
percentage changePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
AP Spine L1 BMD-4.096 ± 7.57693.820 ± 2.8253-0.725 ± 2.8558-1.377 ± 6.50000.437 ± 6.1468-0.305 ± 4.2402-1.033 ± 3.4547-0.439 ± 3.7668
AP Spine L2 BMD-1.441 ± 6.4764-0.816 ± 5.89420.454 ± 1.6845-0.200 ± 8.7398-0.940 ± 2.1560-0.890 ± 5.08540.609 ± 3.82451.060 ± 3.9478
AP Spine L3 BMD1.467 ± 5.3680-1.172 ± 6.46370.237 ± 3.0146-3.332 ± 4.58170.942 ± 2.88900.973 ± 5.38940.793 ± 4.8739-1.330 ± 3.1723
AP Spine L4 BMD-1.908 ± 4.75412.443 ± 6.4076-1.553 ± 3.74241.228 ± 7.7207-0.171 ± 3.68230.470 ± 5.27630.171 ± 3.7706-1.288 ± 3.6274
AP Spine Total L1-L4 BMD-1.356 ± 3.39470.975 ± 4.5713-0.914 ± 2.2948-0.918 ± 5.86890.144 ± 2.12320.095 ± 3.42500.206 ± 3.2457-0.794 ± 2.2182
SecondaryFemoral Neck BMD at Day 85

BMD was evaluated by dual energy X-ray absorptiometry (DXA).

Time frame:
Day 85
Reported as:
Mean · Gram per centimeter square
Femoral Neck BMD at Day 85
Gram per centimeter squarePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Femoral Neck BMD at Day 850.7308 ± 0.096880.8357 ± 0.098770.8135 ± 0.101000.7954 ± 0.102950.8666 ± 0.118670.7185 ± 0.074020.8993 ± 0.061020.8362 ± 0.11301
SecondaryFemoral 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
Reported as:
Mean · T-score
Femoral Neck T-Score at Day 85
T-scorePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Femoral Neck T-Score at Day 85-1.2833 ± 0.81833-0.7333 ± 1.55906-1.2833 ± 0.36009-1.7600 ± 0.70922-0.9324 ± 1.14262-1.6500 ± 0.74066-0.8466 ± 0.73385-1.2278 ± 0.57477
SecondaryMean Percentage Change From Baseline in Distal Radius BMD at Day 85

BMD was evaluated by DXA.

Time frame:
Baseline (Day -1), Day 85
Reported as:
Mean · percentage change
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
percentage changePF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Radius BMD-0.138 ± 3.32411.673 ± 5.2845-1.545 ± 3.89331.226 ± 2.53191.387 ± 3.3849-1.223 ± 4.68066.485 ± 7.5097-0.610 ± 6.6493
Ulna BMD-1.014 ± 4.14852.767 ± 6.7007-0.760 ± 2.06823.131 ± 2.89031.207 ± 3.0197-2.595 ± 2.62007.542 ± 7.5636-1.101 ± 7.2397
Forearm Total BMD-8.608 ± 19.60960.716 ± 6.9188-1.253 ± 3.06037.744 ± 13.4882-0.823 ± 7.7854-2.087 ± 2.14966.944 ± 6.45282.439 ± 12.9063
SecondaryPK/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

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PF-04840082 0.3 mg/kg—0/6 (0%)6/6 (100%)
PF-04840082 1.0 mg/kg—0/6 (0%)4/6 (66.7%)
PF-04840082 6.0 mg/kg—0/6 (0%)6/6 (100%)
PF-04840082 24.0 mg/kg—0/6 (0%)5/6 (83.3%)
PF-04840082 3.0 mg/kg—0/8 (0%)5/8 (62.5%)
PF-04840082 12.0 mg/kg—1/8 (12.5%)6/8 (75%)
PF-04840082 18.0 mg/kg—0/8 (0%)6/8 (75%)
Placebo—1/20 (5%)14/20 (70%)
Most frequent serious events
Most frequent serious events
EventPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Clostridium difficile colitisInfections and infestations0/60/60/60/60/81/80/80/20
Atrial flutterCardiac disorders0/60/60/60/60/80/80/81/20
Most frequent other events
Showing 10 of 58
Most frequent other events
EventPF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlacebo
Pain in extremityMusculoskeletal and connective tissue disorders0/60/63/60/60/80/80/81/20
Upper respiratory tract infectionInfections and infestations0/60/61/62/61/83/81/84/20
HeadacheNervous system disorders1/60/60/61/63/82/81/82/20
DysuriaRenal and urinary disorders0/60/62/60/60/80/80/80/20
Musculoskeletal painMusculoskeletal and connective tissue disorders0/61/61/61/62/80/81/81/20
Supraventricular tachycardiaCardiac disorders0/61/60/60/60/80/80/80/20
Eye pruritusEye disorders1/60/60/60/60/80/80/80/20
Abdominal discomfortGastrointestinal disorders0/61/60/60/60/80/80/80/20
Abnormal faecesGastrointestinal disorders1/60/60/60/60/80/80/80/20
ConstipationGastrointestinal disorders0/61/60/60/60/80/80/81/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlaceboTotal
Mean61.3 ± 6.365.0 ± 9.861.0 ± 4.263.3 ± 5.261.3 ± 5.563.6 ± 7.261.3 ± 5.262.8 ± 5.162.5 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)PF-04840082 0.3 mg/kgPF-04840082 1.0 mg/kgPF-04840082 6.0 mg/kgPF-04840082 24.0 mg/kgPF-04840082 3.0 mg/kgPF-04840082 12.0 mg/kgPF-04840082 18.0 mg/kgPlaceboTotal
Female66664441450
Male0000444618
08

Study locations

8 sites
  • Ambulatory Diagnostic Center
    Coral Gables, Florida 33134, United States
  • Gable Diagnostics
    Coral Gables, Florida 33134, United States
  • Gables Diagnostics
    Coral Gables, Florida 33134, United States
  • SeaView Research, Inc.
    Miami, Florida 33126, United States
  • SeaView Research, Inc.
    Miami, Florida 33134, United States
  • Miami Research Associates
    Miami, Florida 33143, United States
  • MRA Clinical Research
    South Miami, Florida 33143, United States
  • Vince and Associates Clinical Research
    Overland Park, Kansas 66212, United States
09

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2011 to primary completion in May 2012, 13 months.

Results were first posted in Sep 2024, 12 years 4 months after primary completion.

Of 11 phase 1 interventional studies under Bone Diseases, Metabolic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's 13 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2011
First posted
Feb 10, 2011
StartActual
Apr 1, 2011
Primary completionActual
May 24, 2012
CompletionActual
May 24, 2012
Results first posted
Sep 24, 2024
Last update
Sep 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01293487
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 10, 2011
Start date
Apr 1, 2011
Primary completion
May 24, 2012
Completion
May 24, 2012
Results posted
Sep 24, 2024
Last update
Sep 24, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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