HealthyPhase 1NCT01742078
A Study of LY2541546 in Healthy Postmenopausal Women
A Phase 1 study testing LY2541546 - IV and LY2541546 - SC in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY2541546 - IV and LY2541546 - SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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, 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, 46202
About this study
Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women
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.
- Conditions
- Healthy
- Being tested
- LY2541546 - IV, LY2541546 - SC, Placebo
- Keywords
- Postmenopausal females, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2541546 - IVDrug
Also called Blosozumab
Administered IV
LY2541546 - SCDrug
Administered SC
PlaceboDrug
Administered IV or SC
| Study group | Role | What they receive |
|---|---|---|
| 7.5 mg LY2541546 - IV | Experimental | Single dose of 7.5 mg LY2541546 administered intravenously (IV) Receives: Drug: LY2541546 - IV |
| 25 mg LY2541546 - IV | Experimental | Single dose of 25 mg LY2541546 administered IV Receives: Drug: LY2541546 - IV |
| 75 mg LY2541546 - IV | Experimental | Single dose of 75 mg LY2541546 administered IV Receives: Drug: LY2541546 - IV |
| 225 mg LY2541546 - IV | Experimental | Single dose of 225 mg LY2541546 administered IV Receives: Drug: LY2541546 - IV |
| 750 mg LY2541546 - IV | Experimental | Single dose of 750 mg LY2541546 administered IV Receives: Drug: LY2541546 - IV |
| 150 mg LY2541546 - SC | Experimental | Single dose of 150 mg LY2541546 administered subcutaneous (SC) Receives: Drug: LY2541546 - SC |
| Placebo | Placebo comparator | Single dose of placebo administered IV or SC Receives: Drug: Placebo |
| 225 mg LY2541546 - IV, OL | Experimental | Single dose of 225 mg LY2541546 administered IV, open label (OL) Receives: Drug: LY2541546 - IV |
| 750 mg LY2541546 - IV, OL | Experimental | Single dose of 750 mg LY2541546 administered IV, OL Receives: Drug: LY2541546 - IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is any AE from this study that results in one of the following outcomes:
- death
- initial or prolonged inpatient hospitalization
- a life-threatening experience (that is, immediate risk of dying)
- persistent or significant disability/incapacity
- congenital anomaly/birth defect
- or is considered significant by the investigator for any other reason.
Measured: Day 1 through Day 85
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
Measured: 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
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan.
Measured: Baseline (predose), Day 29 anytime, Day 85 anytime
Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.
Measured: Baseline (predose), Day 29 anytime, Day 85 anytime
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.
Measured: Day 1: Predose, Day 29 anytime, Day 85 anytime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742078
- Sponsor's protocol ID
- 11952
- Other IDs
- I2M-MC-GSDA
- Status last verified
- Aug 2018
- First submitted
- 3 Dec 2012
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01742078
- Acronym / sponsor ID
- 11952
- Conditions
- Healthy
- Keywords
- Postmenopausal females, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 7.5 mg LY2541546 - IV | Experimental | Drug: LY2541546 - IVSingle dose of 7.5 mg LY2541546 administered intravenously (IV) |
| 25 mg LY2541546 - IV | Experimental | Drug: LY2541546 - IVSingle dose of 25 mg LY2541546 administered IV |
| 75 mg LY2541546 - IV | Experimental | Drug: LY2541546 - IVSingle dose of 75 mg LY2541546 administered IV |
| 225 mg LY2541546 - IV | Experimental | Drug: LY2541546 - IVSingle dose of 225 mg LY2541546 administered IV |
| 750 mg LY2541546 - IV | Experimental | Drug: LY2541546 - IVSingle dose of 750 mg LY2541546 administered IV |
| 150 mg LY2541546 - SC | Experimental | Drug: LY2541546 - SCSingle dose of 150 mg LY2541546 administered subcutaneous (SC) |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of placebo administered IV or SC |
| 225 mg LY2541546 - IV, OL | Experimental | Drug: LY2541546 - IVSingle dose of 225 mg LY2541546 administered IV, open label (OL) |
| 750 mg LY2541546 - IV, OL | Experimental | Drug: LY2541546 - IVSingle dose of 750 mg LY2541546 administered IV, OL |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2541546 - IVAlso: BlosozumabAdministered IV | Drug | 225 mg LY2541546 - IV, 225 mg LY2541546 - IV, OL, 25 mg LY2541546 - IV, 7.5 mg LY2541546 - IV, 75 mg LY2541546 - IV, 750 mg LY2541546 - IV, 750 mg LY2541546 - IV, OL |
| LY2541546 - SCAdministered SC | Drug | 150 mg LY2541546 - SC |
| PlaceboAdministered IV or SC | Drug | Placebo |
Primary outcome
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
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * or is considered significant by the investigator for any other reason.
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
Time frame: 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
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
Time frame: Baseline (predose), Day 29 anytime, Day 85 anytime
Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Time frame: Baseline (predose), Day 29 anytime, Day 85 anytime
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Time frame: Day 1: Predose, Day 29 anytime, Day 85 anytime
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2541546 - IV and LY2541546 - SC in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.