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OpenTrials
Completed

NCT Number: NCT01742078

A Study of LY2541546 in Healthy Postmenopausal Women

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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Key information

Conditions

Healthy

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2541546 - IV

Drug

Administered IV

Other names: Blosozumab

LY2541546 - SC

Drug

Administered SC

Placebo

Drug

Administered IV or SC

Primary outcomes

  1. 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

    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 outcomes

  1. 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 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime

  2. Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)

    Time frame: 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.

  3. 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

    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.

  4. Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2012
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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