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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02337387 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
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Scientific title:
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A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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28 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02337387 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Bulgaria
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United States
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Part A: Overtly healthy postmenopausal (PMP) females
- Part B: PMP women who are currently taking oral bisphosphonates for prevention or
treatment of osteoporosis
- Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter
(kg/m^2)
Exclusion Criteria:
- Have known allergies to blosozumab, its constituents, or related compounds
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- History of breast carcinoma
- Fracture of a long bone within 1 year of screening
- Have used teriparatide within 3 years prior to screening
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteoporosis, Postmenopausal
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Intervention(s)
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Biological: Blosozumab
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Other: Placebo
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Primary Outcome(s)
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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: Baseline through Day 85]
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Secondary Outcome(s)
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Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
[Time Frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose]
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Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
[Time Frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose]
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Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
[Time Frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose]
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Secondary ID(s)
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15728
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I2M-MC-GSDT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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