A Study of LY2541546 in Healthy Postmenopausal Women

August 3, 2018 updated by: Eli Lilly and Company

A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47710
        • 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
      • Indianapolis, Indiana, United States, 46202
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 7.5 mg LY2541546 - IV
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab
Experimental: 25 mg LY2541546 - IV
Single dose of 25 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab
Experimental: 75 mg LY2541546 - IV
Single dose of 75 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab
Experimental: 225 mg LY2541546 - IV
Single dose of 225 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab
Experimental: 750 mg LY2541546 - IV
Single dose of 750 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab
Experimental: 150 mg LY2541546 - SC
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Drug: LY2541546 - SC
Administered SC
Placebo Comparator: Placebo
Single dose of placebo administered IV or SC
Drug: Placebo
Administered IV or SC
Experimental: 225 mg LY2541546 - IV, OL
Single dose of 225 mg LY2541546 administered IV, open label (OL)
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab
Experimental: 750 mg LY2541546 - IV, OL
Single dose of 750 mg LY2541546 administered IV, OL
Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 through Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
Baseline (predose), Day 29 anytime, Day 85 anytime
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.
Baseline (predose), Day 29 anytime, Day 85 anytime
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.
Day 1: Predose, Day 29 anytime, Day 85 anytime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11952
  • I2M-MC-GSDA (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe