A Study of LY3050258 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: LY3050258; Drug: Placebo

• Registration Number: NCT02121834
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-24
• Study Start: 2014-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2017-09-27
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Results First Posted: 2018-07-27
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	LY3050258	Daily dose of placebo matching LY3050258 for 28 days.
Placebo	Placebo	Daily dose of placebo matching LY3050258 for 28 days.
LY3050258	LY3050258	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.
LY3050258	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

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.; 🇺🇸 Cypress, California, United States