A Study of LY3050258 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121834
• Other study ID #: 14936
• Secondary ID: I6R-MC-DLAB
• Status: Completed
• Phase: Phase 1
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY3050258

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC t,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
Secondary	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