Healthy
Conditions
Keywords
Postmenopausal females, Volunteers
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 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) | Baseline (predose), Day 29 anytime, Day 85 anytime | 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. |
| Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Baseline (predose), Day 29 anytime, Day 85 anytime | 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. |
| Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1: Predose, Day 29 anytime, Day 85 anytime | A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 7.5 mg LY2541546 - IV Participants received 7.5 mg LY2541546 IV | 6 |
| 25 mg LY2541546 - IV Participants received25 mg LY2541546 IV | 6 |
| 75 mg LY2541546 - IV Participants received 75 mg LY2541546 IV | 6 |
| 225 mg LY2541546 - IV Participants received225 mg LY541546 IV | 6 |
| 750 mg LY2541546 - IV Participants received750 mg LY2541546 IV | 6 |
| 150 mg LY2541546 - SC Participants received 150 mg LY2541546 subcutaneously (SC) | 6 |
| 225 mg LY2541546 - IV, OL Participants received 225 mg LY2541546 IV. Open label(OL) | 6 |
| 750 mg LY2541546 - IV, OL Participants received 750 mg LY2541546 IV, OL | 6 |
| Placebo Participants single dose of placebo administered IV or SC | 12 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 7.5 mg LY2541546 - IV | 25 mg LY2541546 - IV | 75 mg LY2541546 - IV | 225 mg LY2541546 - IV | 750 mg LY2541546 - IV | 150 mg LY2541546 - SC | 225 mg LY2541546 - IV, OL | 750 mg LY2541546 - IV, OL | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 3.7 | 56.3 years STANDARD_DEVIATION 4.6 | 60.0 years STANDARD_DEVIATION 5.3 | 53.6 years STANDARD_DEVIATION 4.6 | 59.0 years STANDARD_DEVIATION 5.7 | 58.5 years STANDARD_DEVIATION 4.5 | 59.7 years STANDARD_DEVIATION 6.7 | 64.2 years STANDARD_DEVIATION 5.9 | 57.1 years STANDARD_DEVIATION 5.2 | 57.9 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized African | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 11 Participants | 55 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized West Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 60 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 6 / 6 | 4 / 6 | 4 / 6 | 4 / 6 | 5 / 6 | 7 / 12 | 6 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: Day 1 through Day 85
Population: All participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5 mg LY2541546 - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 25 mg LY2541546 - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 75 mg LY2541546 - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 225 mg LY2541546 - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 750 mg LY2541546 - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 150 mg LY2541546 - SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 225 mg LY2541546 - IV, OL | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 750 mg LY2541546 - IV, OL | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
Secondary
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.
Time frame: Day 1: Predose, Day 29 anytime, Day 85 anytime
Population: All participants who received study drug and had evaluable results at the analyzed time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| 7.5 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 7.5 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 0 Participants |
| 25 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 25 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 0 Participants |
| 25 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| 75 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 1 Participants |
| 75 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 75 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| 225 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 225 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 4 Participants |
| 225 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 2 Participants |
| 750 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| 750 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 1 Participants |
| 750 mg LY2541546 - IV | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 150 mg LY2541546 - SC | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 150 mg LY2541546 - SC | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 2 Participants |
| 150 mg LY2541546 - SC | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| Placebo | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| Placebo | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| Placebo | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 0 Participants |
| 225 mg LY2541546 - IV, OL | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
| 225 mg LY2541546 - IV, OL | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 225 mg LY2541546 - IV, OL | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 0 Participants |
| 750 mg LY2541546 - IV, OL | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 1 | 0 Participants |
| 750 mg LY2541546 - IV, OL | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 85 | 2 Participants |
| 750 mg LY2541546 - IV, OL | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | Day 29 | 0 Participants |
Secondary
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.
Time frame: Baseline (predose), Day 29 anytime, Day 85 anytime
Population: All participants who received study drug and had evaluable results at the analyzed time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 7.5 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | 0.01 gram per square centimeter (g/cm^2) |
| 7.5 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | -0.00 gram per square centimeter (g/cm^2) |
| 25 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | -0.01 gram per square centimeter (g/cm^2) |
| 25 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | -0.01 gram per square centimeter (g/cm^2) |
| 75 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | 0.01 gram per square centimeter (g/cm^2) |
| 75 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | 0.01 gram per square centimeter (g/cm^2) |
| 225 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | 0.01 gram per square centimeter (g/cm^2) |
| 225 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | 0.02 gram per square centimeter (g/cm^2) |
| 750 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | 0.00 gram per square centimeter (g/cm^2) |
| 750 mg LY2541546 - IV | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | 0.03 gram per square centimeter (g/cm^2) |
| 150 mg LY2541546 - SC | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | 0.01 gram per square centimeter (g/cm^2) |
| 150 mg LY2541546 - SC | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | 0.00 gram per square centimeter (g/cm^2) |
| Placebo | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | -0.00 gram per square centimeter (g/cm^2) |
| Placebo | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | -0.00 gram per square centimeter (g/cm^2) |
| 225 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | 0.01 gram per square centimeter (g/cm^2) |
| 225 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | 0.01 gram per square centimeter (g/cm^2) |
| 750 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 29 | -0.00 gram per square centimeter (g/cm^2) |
| 750 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) | Day 85 | 0.02 gram per square centimeter (g/cm^2) |
Secondary
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.
Time frame: Baseline (predose), Day 29 anytime, Day 85 anytime
Population: All participants who received study drug and had evaluable results at the analyzed timepoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 7.5 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 9.36 percentage of change from baseline |
| 7.5 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 9.28 percentage of change from baseline |
| 25 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 44.00 percentage of change from baseline |
| 25 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 25.77 percentage of change from baseline |
| 75 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 24.86 percentage of change from baseline |
| 75 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 14.27 percentage of change from baseline |
| 225 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 47.54 percentage of change from baseline |
| 225 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 24.07 percentage of change from baseline |
| 750 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 224.16 percentage of change from baseline |
| 750 mg LY2541546 - IV | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 33.84 percentage of change from baseline |
| 150 mg LY2541546 - SC | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 19.24 percentage of change from baseline |
| 150 mg LY2541546 - SC | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 31.42 percentage of change from baseline |
| Placebo | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 9.86 percentage of change from baseline |
| Placebo | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 6.18 percentage of change from baseline |
| 225 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 106.76 percentage of change from baseline |
| 225 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 33.59 percentage of change from baseline |
| 750 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 29 | 334.52 percentage of change from baseline |
| 750 mg LY2541546 - IV, OL | Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) | Day 85 | 23.98 percentage of change from baseline |
Secondary
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
Population: All participants who received study drug and had sufficient evaluable results for PK analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 7.5 mg LY2541546 - IV | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 411 picomol*hr/mL | Geometric Coefficient of Variation 51 |
| 25 mg LY2541546 - IV | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 2540 picomol*hr/mL | Geometric Coefficient of Variation 22 |
| 75 mg LY2541546 - IV | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 16400 picomol*hr/mL | Geometric Coefficient of Variation 16 |
| 225 mg LY2541546 - IV | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 86600 picomol*hr/mL | Geometric Coefficient of Variation 14 |
| 750 mg LY2541546 - IV | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 390000 picomol*hr/mL | Geometric Coefficient of Variation 14 |
| 150 mg LY2541546 - SC | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 9150 picomol*hr/mL | Geometric Coefficient of Variation 40 |
| Placebo | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 94500 picomol*hr/mL | Geometric Coefficient of Variation 10 |
| 225 mg LY2541546 - IV, OL | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 | 507000 picomol*hr/mL | Geometric Coefficient of Variation 14 |