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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

February 9, 2011
June 20, 2012
April 2011
May 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01293487 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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(0-) [ Time Frame: Days 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
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

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteopenia
  • Osteoporosis
  • Bone Disease
Biological: RN564
Intravenous, single dose with experimental dose
Experimental: Arm 1
Intervention: Biological: RN564
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
55 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01293487
B1151001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP