NCT01929707

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed
Last Updated

August 27, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

August 23, 2013

Results QC Date

September 27, 2017

Last Update Submit

July 26, 2018

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

LY3050258

EXPERIMENTAL

Single escalating dose of LY3050258 (2 milligram \[mg\] up to 200 mg) administered in up to two of two periods.

Drug: LY3050258

Placebo

PLACEBO COMPARATOR

Single dose of placebo matching LY3050258 administered in up to one of two periods.

Drug: Placebo

Interventions

LY3050258DRUG
LY3050258
PlaceboDRUG
Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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.

New York, New York, 10013, United States

Location

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 27, 2018

Results First Posted

July 23, 2018

Record last verified: 2018-07

Locations

US(1)