Overview

A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eli Lilly and Company
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)