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A Multiple Dose 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:
NCT01742091
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.


Condition Intervention Phase
Healthy
Drug: LY2541546 - SC
Drug: LY2541546 - IV
Drug: Placebo - SC
Drug: Placebo - IV
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 Multiple Dose Study of LY2541546 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics 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 141 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546 [ Time Frame: Day 1 through Day 141 ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD): Lumbar Spine Bone Mineral Density [ Time Frame: Predose and 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, 85 and 141) ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD): N-terminal Propeptide of Procollagen Type 1 (P1NP) [ Time Frame: Predose through Day 141 ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 180 mg LY2541546 SC Q4W
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
Drug: LY2541546 - SC
Administered SC
Drug: Placebo - SC
Administered SC
Experimental: 270 mg LY2541546 SC Q2W
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
Drug: LY2541546 - SC
Administered SC
Experimental: 270 mg LY2541546 SC Q4W
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
Drug: LY2541546 - SC
Administered SC
Drug: Placebo - SC
Administered SC
Experimental: 540 mg LY2541546 IV Q4W
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
Drug: LY2541546 - IV
Administered IV
Drug: Placebo - IV
Administered IV
Experimental: 750 mg LY2541546 IV Q2W
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
Drug: LY2541546 - IV
Administered IV
Placebo Comparator: Placebo Q2W
Placebo administered IV or SC once every 2 weeks for 8 weeks.
Drug: Placebo - SC
Administered SC
Drug: Placebo - IV
Administered IV

  Eligibility

Ages Eligible for Study:   45 Years to 80 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

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
  • Have received study treatment in any trial of an investigational osteoporosis treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12 weeks of screening or 5 half-lives, whichever is longer
  • Known allergies to LY2541546, its constituents, or related compounds
  • Persons who have previously participated in this study or any other study of LY2541546
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • History or presence of low platelet count, bleeding issues or family history of bleeding disorders
  • 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
  • Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study or to abide by the clinical research unit restrictions. Note: Average weekly alcohol intake must not exceed 14 units per week
  • Are unable or unwilling to refrain from nicotine usage during Clinical Research Unit (CRU) confinement
  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: NCT01742091

Locations
United States, Florida
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.
Daytona Beach, Florida, United States, 32117
United States, Hawaii
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.
Honolulu, Hawaii, United States, 96813
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
United States, Texas
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.
Austin, Texas, United States, 78752
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.
Dallas, Texas, United States, 75247
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: NCT01742091     History of Changes
Other Study ID Numbers: 13405, I2M-MC-GSDE
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 24, 2014