A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Osteoporosis, Postmenopausal Syndrome |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 7/18/2018 |
| Start Date: | April 2014 |
| End Date: | July 2014 |
A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
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.
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.
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)
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