A Study of LY3050258 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.

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

Conditions
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Healthy Participants

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 Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2) Exclusion Criteria: An abnormal sitting blood pressure as determined by the investigator Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation Current use of statins within the last 3 months prior to dosing Current or previous use of anabolic steroids in the preceding 6 months prior to dosing Use of dehydroepiandrosterone, other potential over-the-counter (OTC) 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3050258<br>Single escalating dose of LY3050258 (2 milligram [mg] up to 200 mg) administered in up to two of two periods. | Drug: LY3050258<br> <br> |
| Placebo Comparator: Placebo<br>Single dose of placebo matching LY3050258 administered in up to one of two periods. | 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 | Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module. | Baseline up to 21 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 |  | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose. | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 |  | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose |