A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109042
• Other study ID #: 15172
• Secondary ID: I2M-MC-GSDM
• Status: Completed
• Phase: Phase 1
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Blosozumab
Administered subcutaneously

Locations

Country	Name	City	State
United States	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.	Dallas	Texas
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab	The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.	Predose and daily up through 7 days postdose
Primary	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.	Predose and daily up through 7 days postdose