A Study of LY2541546 in Healthy Postmenopausal Women
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
Key facts
- Study ID
- NCT01742078
- Run by
- Eli Lilly and Company
- People needed
- 60
- Starts
- 2008-06-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2019-01-23
Who can join
Age: 45 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Healthy postmenopausal females, as determined by medical history and physical examination
- Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive
- Acceptable Clinical laboratory test results, blood pressure and heart rate
- Have given written informed consent
- Additional Inclusion Criterion for Participants in Open Label Groups: Are currently taking or recently discontinued (not more than 3 months prior to study randomization) alendronate and have taken alendronate for at least 12 of the last 18 months
You may not qualify if…
- Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
- Known allergies to LY2541546, its constituents, or related compounds
- Persons who have previously participated in this study
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- History of or high risk for adverse outcome from bleeding, for example, transient ischemic attacks, cerebrovascular attacks, and ulcer disease
- Paget's disease, parathyroid disease, or thyroid disease
- Fracture of a long bone within 12 weeks of screening
- Regular use of known drugs of abuse and/or positive findings on urinary drug screening
- Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen
- Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months
- Blood donation within the last month
- Participants who have an average weekly alcohol intake that exceeds 14 units per week
- Cigarette consumption of more than 10 cigarettes per day, or are unable or unwilling to refrain from nicotine during Clinical Research Unit (CRU) confinement
- Additional Exclusion Criterion for Participants in Double Blind Groups Only
- Have received bisphosphonates during the previous 24 months.
- Additional Exclusion Criterion for Participants in Open Label Groups
- Have received intravenous bisphosphonates within the previous 18 months
Where it is running
- 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 — Evansville, Indiana, 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 — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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