A Study of LY2541546 in Healthy Postmenopausal Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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7.5 mg LY2541546 - IV

Single dose of 7.5 mg LY2541546 administered intravenously (IV)

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

25 mg LY2541546 - IV

Single dose of 25 mg LY2541546 administered IV

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

75 mg LY2541546 - IV

Single dose of 75 mg LY2541546 administered IV

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

225 mg LY2541546 - IV

Single dose of 225 mg LY2541546 administered IV

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

750 mg LY2541546 - IV

Single dose of 750 mg LY2541546 administered IV

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

150 mg LY2541546 - SC

Single dose of 150 mg LY2541546 administered subcutaneous (SC)

Group Type EXPERIMENTAL

LY2541546 - SC

Intervention Type DRUG

Administered SC

Placebo

Single dose of placebo administered IV or SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV or SC

225 mg LY2541546 - IV, OL

Single dose of 225 mg LY2541546 administered IV, open label (OL)

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

750 mg LY2541546 - IV, OL

Single dose of 750 mg LY2541546 administered IV, OL

Group Type EXPERIMENTAL

LY2541546 - IV

Intervention Type DRUG

Administered IV

Interventions

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LY2541546 - IV

Administered IV

Intervention Type DRUG

LY2541546 - SC

Administered SC

Intervention Type DRUG

Placebo

Administered IV or SC

Intervention Type DRUG

Other Intervention Names

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Blosozumab

Eligibility Criteria

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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

* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes