A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Blosozumab
Weekly SC injections of blosozumab for 6 weeks.
Intervention: Blosozumab (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
Time Frame: Predose and daily up through 7 days postdose
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
PK: Area Under the Concentration Curve of Blosozumab
Time Frame: Predose and daily up through 7 days postdose
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
Secondary Outcomes
No secondary outcomes reported