Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01293487
First received: February 9, 2011
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteopenia Osteoporosis Bone Disease |
Biological: RN564 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase I Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of RN564 In Women With Osteopenia And In Healthy Men |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Incidence of dose limiting or intolerable treatment related adverse events (AEs) [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
- Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
- Incidence of abnormal laboratory findings (clinical chemistry, hematology and urinalysis) [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
- Changes from baseline in safety laboratory assessments. [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
- Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The PK parameter estimates will include but not be limited to: AUC(0-t[last]), Tmax, Cmax, terminal elimination half-life (t1/2), Clearance (CL), apparent volume of distribution (Vz), volume of distribution at steady state (Vss), and AUC of RN564. [ Time Frame: Days 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 ] [ Designated as safety issue: Yes ]
- Percentage change from baseline (average of Day -1 and Day 1 prior to infusion of RN564) in total DKK-1 concentrations over time inclusive of 85 days. [ Time Frame: Days -1, 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 ] [ Designated as safety issue: No ]
- Percentage change from baseline (average of Day -1 and Day 1 prior to infusion of RN564) in serum PINP, NTX, CTX, bone specific alkaline phosphatase and osteocalcin over time inclusive of 85 days. [ Time Frame: Days -1, 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 ] [ Designated as safety issue: No ]
- Percentage change from baseline in lumbar spine, total hip, femoral neck and distal radius BMD at Day 85. [ Time Frame: Day -1 and 85 ] [ Designated as safety issue: No ]
- PK/PD model describing the relationship between RN564 PK parameter estimates/concentrations and changes in pharmacodynamic endpoints. [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
| Enrollment: | 68 |
| Study Start Date: | April 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Biological: RN564
Intravenous, single dose with experimental dose
|
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293487
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33134 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33126 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33143 | |
| Pfizer Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01293487 History of Changes |
| Other Study ID Numbers: | B1151001 |
| Study First Received: | February 9, 2011 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 Osteopenia RN564 |
Additional relevant MeSH terms:
|
Bone Diseases Bone Diseases, Metabolic Osteoporosis Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013