NCT01742078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

December 3, 2012

Results QC Date

November 22, 2013

Last Update Submit

August 3, 2018

Conditions

Healthy

Keywords

Postmenopausal femalesVolunteers

Outcome Measures

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

    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 Outcomes (4)

  • 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

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

    Baseline (predose), Day 29 anytime, Day 85 anytime

  • Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)

    Baseline (predose), Day 29 anytime, Day 85 anytime

  • Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies

    Day 1: Predose, Day 29 anytime, Day 85 anytime

Study Arms (9)

7.5 mg LY2541546 - IV

EXPERIMENTAL

Single dose of 7.5 mg LY2541546 administered intravenously (IV)

Drug: LY2541546 - IV

25 mg LY2541546 - IV

EXPERIMENTAL

Single dose of 25 mg LY2541546 administered IV

Drug: LY2541546 - IV

75 mg LY2541546 - IV

EXPERIMENTAL

Single dose of 75 mg LY2541546 administered IV

Drug: LY2541546 - IV

225 mg LY2541546 - IV

EXPERIMENTAL

Single dose of 225 mg LY2541546 administered IV

Drug: LY2541546 - IV

750 mg LY2541546 - IV

EXPERIMENTAL

Single dose of 750 mg LY2541546 administered IV

Drug: LY2541546 - IV

150 mg LY2541546 - SC

EXPERIMENTAL

Single dose of 150 mg LY2541546 administered subcutaneous (SC)

Drug: LY2541546 - SC

Placebo

PLACEBO COMPARATOR

Single dose of placebo administered IV or SC

Drug: Placebo

225 mg LY2541546 - IV, OL

EXPERIMENTAL

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

Drug: LY2541546 - IV

750 mg LY2541546 - IV, OL

EXPERIMENTAL

Single dose of 750 mg LY2541546 administered IV, OL

Drug: LY2541546 - IV

Interventions

LY2541546 - IVDRUG

Administered IV

Also known as: Blosozumab
225 mg LY2541546 - IV225 mg LY2541546 - IV, OL25 mg LY2541546 - IV7.5 mg LY2541546 - IV75 mg LY2541546 - IV750 mg LY2541546 - IV750 mg LY2541546 - IV, OL
LY2541546 - SCDRUG

Administered SC

150 mg LY2541546 - SC
PlaceboDRUG

Administered IV or SC

Placebo

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Have received bisphosphonates during the previous 24 months.
  • Have received intravenous bisphosphonates within the previous 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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, 47710, United States

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

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

blosozumab

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 23, 2019

Results First Posted

January 23, 2019

Record last verified: 2018-08

Locations

US(2)