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A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Blosozumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis, Postmenopausal

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Part A: Overtly healthy PMP females
  • Part B: PMP women who are currently taking oral bisphosphonates
  • Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)

Exclusion Criteria:

  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Have known allergies to blosozumab, its constituents, or related compounds
  • Have an abnormality in the 12-lead electrocardiogram (ECG)

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blosozumab

Arm Description

Weekly SC injections of blosozumab for 6 weeks.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
PK: Area Under the Concentration Curve of Blosozumab
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
September 27, 2017
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02109042
Brief Title
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
Official Title
A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected. This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug. There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blosozumab
Arm Type
Experimental
Arm Description
Weekly SC injections of blosozumab for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Blosozumab
Other Intervention Name(s)
LY2541546
Intervention Description
Administered subcutaneously
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
Description
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
Time Frame
Predose and daily up through 7 days postdose
Title
PK: Area Under the Concentration Curve of Blosozumab
Description
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
Time Frame
Predose and daily up through 7 days postdose

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Part A: Overtly healthy PMP females Part B: PMP women who are currently taking oral bisphosphonates Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2) Exclusion Criteria: Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Show evidence of hepatitis C and/or positive hepatitis C antibody Show evidence of hepatitis B and/or positive hepatitis B surface antigen Have known allergies to blosozumab, its constituents, or related compounds Have an abnormality in the 12-lead electrocardiogram (ECG)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States

12. IPD Sharing Statement

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A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

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