Indianapolis, Indiana 46202

  • Healthy

Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

11952


NCT ID:

NCT01742078


Secondary ID:

I2M-MC-GSDA


Study Acronym:


Brief Title:

A Study of LY2541546 in Healthy Postmenopausal Women


Official Title:

A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

45 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

9


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Study Dates

Start Date:June 2008
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:June 2010
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 3, 2018
First Received Date:December 3, 2012
First Results Date:November 22, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Time Frame:Day 1: Predose, Day 29 anytime, Day 85 anytime
Safety Issues:False
Description:A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.
Outcome Type:Secondary Outcome
Measure:Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Time Frame:Baseline (predose), Day 29 anytime, Day 85 anytime
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
Time Frame:Baseline (predose), Day 29 anytime, Day 85 anytime
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
Time Frame:Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame:Day 1 through Day 85
Safety Issues:False
Description: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 cong

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Administered IV or SC
Arm Name:Placebo
Intervention Type:Drug
Name:LY2541546 - SC
Description:Administered SC
Arm Name:150 mg LY2541546 - SC
Intervention Type:Drug
Name:LY2541546 - IV
Description:Administered IV
Arm Name:7.5 mg LY2541546 - IV
Other Name:Blosozumab

Study Arms

Study Arm Type:Experimental
Arm Name:750 mg LY2541546 - IV, OL
Description:Single dose of 750 mg LY2541546 administered IV, OL
Study Arm Type:Experimental
Arm Name:225 mg LY2541546 - IV, OL
Description:Single dose of 225 mg LY2541546 administered IV, open label (OL)
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Single dose of placebo administered IV or SC
Study Arm Type:Experimental
Arm Name:150 mg LY2541546 - SC
Description:Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Study Arm Type:Experimental
Arm Name:750 mg LY2541546 - IV
Description:Single dose of 750 mg LY2541546 administered IV
Study Arm Type:Experimental
Arm Name:225 mg LY2541546 - IV
Description:Single dose of 225 mg LY2541546 administered IV
Study Arm Type:Experimental
Arm Name:75 mg LY2541546 - IV
Description:Single dose of 75 mg LY2541546 administered IV
Study Arm Type:Experimental
Arm Name:25 mg LY2541546 - IV
Description:Single dose of 25 mg LY2541546 administered IV
Study Arm Type:Experimental
Arm Name:7.5 mg LY2541546 - IV
Description:Single dose of 7.5 mg LY2541546 administered intravenously (IV)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 25, 2021

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