A Study of LY2541546 in Healthy Postmenopausal Women

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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
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

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
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

Additional Exclusion Criterion for Participants in Open Label Groups

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single dose of placebo administered IV or SC
225 mg LY2541546 - IV	LY2541546 - IV	Single dose of 225 mg LY2541546 administered IV
225 mg LY2541546 - IV, OL	LY2541546 - IV	Single dose of 225 mg LY2541546 administered IV, open label (OL)
75 mg LY2541546 - IV	LY2541546 - IV	Single dose of 75 mg LY2541546 administered IV
150 mg LY2541546 - SC	LY2541546 - SC	Single dose of 150 mg LY2541546 administered subcutaneous (SC)
7.5 mg LY2541546 - IV	LY2541546 - IV	Single dose of 7.5 mg LY2541546 administered intravenously (IV)
25 mg LY2541546 - IV	LY2541546 - IV	Single dose of 25 mg LY2541546 administered IV
750 mg LY2541546 - IV	LY2541546 - IV	Single dose of 750 mg LY2541546 administered IV
750 mg LY2541546 - IV, OL	LY2541546 - IV	Single dose of 750 mg LY2541546 administered IV, OL

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Day 1 through Day 85	An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * or is considered significant by the investigator for any other reason.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)	Baseline (predose), Day 29 anytime, Day 85 anytime	N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)	Baseline (predose), Day 29 anytime, Day 85 anytime	A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan.
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies	Day 1: Predose, Day 29 anytime, Day 85 anytime	A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546	Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime

Locations (1): 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
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Indianapolis, Indiana, United States