A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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., Daytona Beach, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blosozumab

Drug

Administered subcutaneously

Other names: LY2541546

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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Apr 9, 2014
Registry last updated: Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed