A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:

A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02337387
• Other study ID #: 15728
• Secondary ID: I2M-MC-GSDT
• Status: Terminated
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: August 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause.

This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Part A: Overtly healthy postmenopausal (PMP) females

• Part B: PMP women who are currently taking oral bisphosphonates for prevention or treatment of osteoporosis

• Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)

Exclusion Criteria:

• Have known allergies to blosozumab, its constituents, or related compounds

• Have an abnormality in the 12-lead electrocardiogram (ECG)

• History of breast carcinoma

• Fracture of a long bone within 1 year of screening

• Have used teriparatide within 3 years prior to screening

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Biological:
• Blosozumab
Administered SC

Other:
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas
United States	Covance	Daytona Beach	Florida
United States	Covance Clinical Research Inc	Evansville	Indiana

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	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.	Baseline through Day 85
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B		Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Secondary	Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B		Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Secondary	Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B		Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose