A Study of LY3050258 in Healthy Participants

NCT ID: NCT02121834

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

LY3050258

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo

Daily dose of placebo matching LY3050258 for 28 days.

Group Type: PLACEBO_COMPARATOR

LY3050258

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

LY3050258

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

I6R-MC-DLAB

Identifier Type: OTHER

Identifier Source: secondary_id

14936

Identifier Type: -

Identifier Source: org_study_id