Clinical trial NCT01742078: A Study of LY2541546 in Healthy Postmenopausal Women
Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Postmenopausal females
Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Day 1 through Day 85
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
timeFrame: 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
measure: Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
timeFrame: Baseline (predose), Day 29 anytime, Day 85 anytime
measure: Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
timeFrame: Baseline (predose), Day 29 anytime, Day 85 anytime
measure: Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
timeFrame: Day 1: Predose, Day 29 anytime, Day 85 anytime
Other outcomes:
Locations:
city: Evansville
country: United States
facility: 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
state: Indiana
city: Indianapolis
country: United States
facility: 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
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: