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A Study of LY2541546 in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01742078
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
  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.


Condition Intervention Phase
Healthy
Drug: LY2541546 - IV
Drug: LY2541546 - SC
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve from Time Zero to Infinity (AUC0-∞) of LY2541546 [ Time Frame: Day 1 through Day 85 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD): Lumbar Spine Bone Mineral Density [ Time Frame: Predose (Day 1) and Postdose (Day 29 and 85) ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD): N-terminal Propeptide of Procollagen Type 1 (P1NP) [ Time Frame: Predose through Day 85 ] [ Designated as safety issue: No ]
  • Immunogenicity: The Number of Participants with Anti-LY2541546 Antibodies [ Time Frame: Predose (Day 1) and Postdose (Day 29 and 85) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7.5 mg LY2541546 - IV
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Drug: LY2541546 - IV
Administered IV
Experimental: 25 mg LY2541546 - IV
Single dose of 25 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Experimental: 75 mg LY2541546 - IV
Single dose of 75 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Experimental: 225 mg LY2541546 - IV
Single dose of 225 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
Experimental: 750 mg LY2541546 - IV
Single dose of 750 mg LY2541546 administered IV
Drug: LY2541546 - IV
Administered IV
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
Experimental: 750 mg LY2541546 - IV, OL
Single dose of 750 mg LY2541546 administered IV, OL
Drug: LY2541546 - IV
Administered IV

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742078

Locations
United States, Indiana
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, 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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01742078     History of Changes
Other Study ID Numbers: 11952, I2M-MC-GSDA
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Postmenopausal females
Volunteers

ClinicalTrials.gov processed this record on November 27, 2014