Healthy Volunteers
Conditions
Brief summary
This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This study will evaluate the safety and how well the body tolerates LY3050258. It will last approximately 14 weeks with a 2 week follow-up appointment after the last treatment with study drug.
Interventions
DRUGLY3050258
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or healthy postmenopausal females, including Japanese participants * Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m\^2), inclusive
Exclusion criteria
* Abnormal siting blood pressure as determined by the investigator * Abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation * Aspartate aminotransferase (AST) or alkaline phosphatase (ALT) greater than 2 times the upper limit of normal (ULN) * Skin condition that in the opinion of the investigator makes the participant unsuitable for study participation * Current use of statins within the last 3 months prior to dosing * Current use or previous use of anabolic steroids in the preceding 6 months prior to dosing * Use of dehydroepiandrosterone, other potential over-the-counter steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing
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 | Baseline to Study Completion (Up to 14 Weeks) | Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A-D Placebo Placebo daily for 28 days | 12 |
| Cohort A: LY3050258 10 mg LY3050258, daily for 28 days | 11 |
| Cohort B: LY3050258 30 mg LY3050258, daily for 28 days | 9 |
| Cohort C: LY3050258 90 mg LY3050258, daily for 28 days | 10 |
| Cohort D: LY3050258 180 mg LY3050258, daily for 28 days | 9 |
| Cohort E: LY3050258 360 mg LY3050258, daily for 28 days | 9 |
| Cohort E Placebo Placebo daily for 28 days | 3 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort A-D Placebo | Total | Cohort E Placebo | Cohort E: LY3050258 | Cohort D: LY3050258 | Cohort C: LY3050258 | Cohort B: LY3050258 | Cohort A: LY3050258 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 12.2 | 48.7 years STANDARD_DEVIATION 10.6 | 35.7 years STANDARD_DEVIATION 5.5 | 47.8 years STANDARD_DEVIATION 10.5 | 44.6 years STANDARD_DEVIATION 10.6 | 52.8 years STANDARD_DEVIATION 10.4 | 51.6 years STANDARD_DEVIATION 9.1 | 50.5 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 17 Participants | 2 Participants | 5 Participants | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 46 Participants | 1 Participants | 4 Participants | 9 Participants | 7 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 15 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 14 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 31 Participants | 2 Participants | 5 Participants | 2 Participants | 6 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 12 Participants | 63 Participants | 3 Participants | 9 Participants | 9 Participants | 10 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Female | 4 Participants | 21 Participants | 0 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 42 Participants | 3 Participants | 6 Participants | 6 Participants | 8 Participants | 6 Participants | 5 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 12 | 4 / 11 | 2 / 9 | 3 / 10 | 6 / 9 | 4 / 9 | 2 / 3 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 3 |
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
Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline to Study Completion (Up to 14 Weeks)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Cohort A-D | 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 |
| 10 mg LY3050258 | 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 |
| 30 mg LY3050258 | 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 |
| 90 mg LY3050258 | 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 |
| 180 mg LY3050258 | 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 |
| 360 mg LY3050258 | 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 Cohort E | 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
Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258
Time frame: Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs
Population: All participants who received at least one dose of study drug and had measurable AUC PK concentrations after dosing.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort A-D | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | 14.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 81 |
| 10 mg LY3050258 | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | 24.1 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 55 |
| 30 mg LY3050258 | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | 55.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 62 |
| 90 mg LY3050258 | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | 70.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 50 |
| 180 mg LY3050258 | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | 84.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 65 |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258
Time frame: Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs
Population: All participants who received at least one dose of study drug and had measurable Cmax PK concentrations after dosing.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Cohort A-D | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | 0.899 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 93 |
| 10 mg LY3050258 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | 1.35 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 63 |
| 30 mg LY3050258 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | 3.58 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 61 |
| 90 mg LY3050258 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | 4.51 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 57 |
| 180 mg LY3050258 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | 4.99 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62 |