A Study of LY3050258 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929707
• Other study ID #: 14935
• Secondary ID: I6R-MC-DLAA
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: December 2013

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• 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

• 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

Related Conditions & MeSH terms

• Healthy Participants

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.	New York	New York

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	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	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.
Secondary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-8)] 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