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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01293487
First received: February 9, 2011
Last updated: June 20, 2012
Last verified: June 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014