Phase 1
N=68
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
Osteopenia · Osteoporosis · Bone Disease
Bottom Line
View on ClinicalTrials.gov: NCT01293487 ↗Enrolled (actual)
68
Serious AEs
2.9%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RN564 (Biological)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With All-Causality AEs by Grade |
100.0; 50.0; 100.0; 66.7; 62.5; 37.5 | — |
| PRIMARY Percentage of Participants With Treatment-Related AEs by Grade |
50.0; 16.7; 50.0; 33.3; 50.0; 0 | — |
| PRIMARY Number of Participants With Any Laboratory Abnormality |
3; 3; 4; 1; 3; 4 | — |
| PRIMARY Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation |
8; -9; 7; 4; -3; -31 | — |
| PRIMARY Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation |
-0.05; -0.07; -0.14; -0.10; 0.05; -0.30 | — |
| PRIMARY Median Change From Baseline in Hematocrit at Last Observation |
0.6; 1.4; -0.8; -0.4; 1.0; -2.4 | — |
| PRIMARY Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation |
-0.3; -0.6; -0.6; -0.1; -0.1; -0.8 | — |
| PRIMARY Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation |
-0.2; -0.1; 0.0; 0.0; -0.2; -0.2 | — |
| PRIMARY Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation |
-1; -0; -1; -1; 0; 0 | — |
| PRIMARY Median Change From Baseline in Liver Function Tests at Last Observation |
-1; 0; -2; 1; 2; 1 | — |
| PRIMARY Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation |
0; 0; 0; -0; 0; 0 | — |
| PRIMARY Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation |
-17; 21; -43; 13; 1; -11 | — |
| PRIMARY Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation |
-0.0; -0.0; -0.0; -0.0; 0.0; 0.0 | — |
| PRIMARY Median Change From Baseline in T4 at Last Observation |
0.3; 0.9; -1.6; 0.0; -0.3; 0.2 | — |
| PRIMARY Median Change From Baseline in Urine WBC at Last Observation |
-1.0; 0.0; -1.0 | — |
| PRIMARY Median Change From Baseline in Urine pH at Last Observation |
0.3; 0.7; 0.3; 0.0; 0.6; -0.3 | — |
| PRIMARY Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure |
3; 0; 0; 0; 0; 3 | — |
| PRIMARY Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
1175; 7588; 86360; 348800; 33960; 171100 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
9.580; 29.20; 205.8; 687.3; 92.05; 409.6 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) |
1.49; 2.05; 2.00; 2.00; 1.56; 2.00 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) |
NA; 3817; 3511; NA; 3822; 3782 | — |
| SECONDARY Clearance (CL) |
7.647; 4.011; 5.729; 4.248; 3.587 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) |
NA; 358.7; 637.8; NA; 486.9; 657.5 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] |
NA; 8655; 97010; NA; 36270; 192600 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
— | — |
| SECONDARY Percentage Change From Baseline in Total Dickkopf-1 (DKK-1) Concentrations Over Time |
— | — |
| SECONDARY Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time |
0.161; 2.836; 11.237; 5.894; 2.366; 2.238 | — |
| SECONDARY Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time |
-4.602; -6.789; -1.247; 19.637; -3.399; -4.220 | — |
| SECONDARY Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time |
3.467; 6.218; 26.444; 9.644; 0.024; 4.756 | — |
| SECONDARY Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time |
-6.185; -2.849; -0.796; -7.570; -0.796; -6.334 | — |
| SECONDARY Mean Percentage Change From Baseline in Serum Osteocalcin Over Time |
5.734; 1.688; 4.798; 0.635; 0.663; -3.061 | — |
| SECONDARY Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 |
-4.096; 3.820; -0.725; -1.377; 0.437; -0.305 | — |
| SECONDARY Femoral Neck BMD at Day 85 |
0.7308; 0.8357; 0.8135; 0.7954; 0.8666; 0.7185 | — |
| SECONDARY Femoral Neck T-Score at Day 85 |
-1.2833; -0.7333; -1.2833; -1.7600; -0.9324; -1.6500 | — |
| SECONDARY Mean Percentage Change From Baseline in Distal Radius BMD at Day 85 |
-0.138; 1.673; -1.545; 1.226; 1.387; -1.223 | — |
| SECONDARY PK/PD Model Describing the Relationship Between PF-04840082 PK Parameter Estimates/Concentrations and Changes in PD Endpoints |
— | — |
Summary
The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the lumbar spine, the femoral neck or total hip)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that are accessible by DXA.
Exclusion Criteria
- Evidence or history of any underlying condition, other than primary osteopenia, that affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism).
- Subjects with pre-existing periodontal/dental disease or those who have undergone invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior to Day -1.
- If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
Data sourced from ClinicalTrials.gov (NCT01293487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.