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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293487
• Other study ID #: B1151001
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2011
• Last updated: June 20, 2012
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Disease
• Bone Diseases
• Osteopenia
• Osteoporosis

Intervention

Biological:
• RN564
Intravenous, single dose with experimental dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting or intolerable treatment related adverse events (AEs)		Duration of the study	Yes
Primary	Incidence, severity and causal relationship of treatment emergent AEs (TEAEs)		Duration of the study	Yes
Primary	Incidence of abnormal laboratory findings (clinical chemistry, hematology and urinalysis)		Duration of the study	Yes
Primary	Changes from baseline in safety laboratory assessments.		Duration of the study	Yes
Primary	Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.		Duration of the study	Yes
Secondary	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.		Days 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85	Yes
Secondary	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.		Days -1, 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85	No
Secondary	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.		Days -1, 1, 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85	No
Secondary	Percentage change from baseline in lumbar spine, total hip, femoral neck and distal radius BMD at Day 85.		Day -1 and 85	No
Secondary	PK/PD model describing the relationship between RN564 PK parameter estimates/concentrations and changes in pharmacodynamic endpoints.		Duration of the study	No

External Links

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