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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02337387
Other study ID # 15728
Secondary ID I2M-MC-GSDT
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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