A Study of LY3050258 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Multiple-Dose, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of LY3050258

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY3050258
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3050258<br>Daily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg. | Drug: LY3050258<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Daily dose of placebo matching LY3050258 for 28 days. | Drug: LY3050258<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Study Completion (Up to 14 Weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |