A Study of LY3050258 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: LY3050258

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3050258; Single escalating dose of LY3050258 (2 milligram [mg] up to 200 mg) administered in up to two of two periods.	Drug: LY3050258
Placebo Comparator: Placebo; Single dose of placebo matching LY3050258 administered in up to one of two periods.	Drug: Placebo

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: August 23, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 14935; I6R-MC-DLAA (Other Identifier: Eli Lilly and Company)