A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY2541546 - SC; Drug: Placebo - SC; Drug: Placebo - IV; Drug: LY2541546 - IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742091

I2M-MC-GSDE (Other Identifier)

13405

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 6 patient groups, including a placebo group

180 mg LY2541546 SC Q4W

Experimental group

Description:

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.

Treatment:

Drug: Placebo - SC

Drug: LY2541546 - SC

270 mg LY2541546 SC Q2W

Experimental group

Description:

270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.

Treatment:

Drug: LY2541546 - SC

270 mg LY2541546 SC Q4W

Experimental group

Description:

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.

Treatment:

Drug: Placebo - SC

Drug: LY2541546 - SC

540 mg LY2541546 IV Q4W

Experimental group

Description:

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.

Treatment:

Drug: LY2541546 - IV

Drug: Placebo - IV

750 mg LY2541546 IV Q2W

Experimental group

Description:

750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.

Treatment:

Drug: LY2541546 - IV

Placebo Q2W

Placebo Comparator group

Description:

Placebo administered IV or SC once every 2 weeks for 8 weeks.

Treatment:

Drug: Placebo - SC

Drug: Placebo - IV