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

Primary Purpose

Osteopenia, Osteoporosis, Bone Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RN564

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Phase 1, Osteopenia, RN564

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Incidence of dose limiting or intolerable treatment related adverse events (AEs)

Incidence, severity and causal relationship of treatment emergent AEs (TEAEs)

Incidence of abnormal laboratory findings (clinical chemistry, hematology and urinalysis)

Changes from baseline in safety laboratory assessments.

Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.

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.

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.

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.

Percentage change from baseline in lumbar spine, total hip, femoral neck and distal radius BMD at Day 85.

PK/PD model describing the relationship between RN564 PK parameter estimates/concentrations and changes in pharmacodynamic endpoints.

Full Information

NCT ID

NCT01293487

First Posted

February 9, 2011

Last Updated

June 20, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01293487

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia, Osteoporosis, Bone Disease

Keywords

Phase 1, Osteopenia, RN564

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

N/A

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

RN564

Intervention Description

Intravenous, single dose with experimental dose

Primary Outcome Measure Information:

Title

Incidence of dose limiting or intolerable treatment related adverse events (AEs)

Time Frame

Duration of the study

Title

Incidence, severity and causal relationship of treatment emergent AEs (TEAEs)

Time Frame

Duration of the study

Title

Incidence of abnormal laboratory findings (clinical chemistry, hematology and urinalysis)

Time Frame

Duration of the study

Title

Changes from baseline in safety laboratory assessments.

Time Frame

Duration of the study

Title

Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.

Time Frame

Duration of the study

Secondary Outcome Measure Information:

Title

Time Frame

Days 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85

Title

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

Title

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

Title

Percentage change from baseline in lumbar spine, total hip, femoral neck and distal radius BMD at Day 85.

Time Frame

Day -1 and 85

Title

PK/PD model describing the relationship between RN564 PK parameter estimates/concentrations and changes in pharmacodynamic endpoints.

Time Frame

Duration of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1151001&StudyName=Safety%20And%20Tolerability%20Study%20Of%20RN564%20In%20Women%20With%20Osteopenia%20And%20Healthy%20Men.

Description

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