A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 45 - 80 |
| Updated: | 7/20/2018 |
| Start Date: | September 2009 |
| End Date: | March 2010 |
A Multiple Dose Study of LY2541546 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Postmenopausal Women
The purpose of this study is to assess the safety and side effects of multiple doses of
LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin)
and intravenously (directly into a vein). The study will also test how long it takes the
study drug to get into the body, how long it takes the body to get rid of it, the overall
effect of the study drug on the body, and whether antibodies to the study drug are formed.
LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin)
and intravenously (directly into a vein). The study will also test how long it takes the
study drug to get into the body, how long it takes the body to get rid of it, the overall
effect of the study drug on the body, and whether antibodies to the study drug are formed.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Have received study treatment in any trial of an investigational osteoporosis
treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12
weeks of screening or 5 half-lives, whichever is longer
- Known allergies to LY2541546, its constituents, or related compounds
- Persons who have previously participated in this study or any other study of LY2541546
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, hematological, or neurological disorders
- History or presence of low platelet count, bleeding issues or family history of
bleeding disorders
- 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
- Are unwilling or unable to maintain their normal pattern of alcohol, caffeine,
smoking, and exercise from the start to the end of the study or to abide by the
clinical research unit restrictions. Note: Average weekly alcohol intake must not
exceed 14 units per week
- Are unable or unwilling to refrain from nicotine usage during Clinical Research Unit
(CRU) confinement
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5
sites
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