NCT02818335

Brief Summary

The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it. The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected. This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug. This study is for research purposes only and is not intended to treat any medical conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2016

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

First Submitted

Initial submission to the registry

June 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

June 28, 2016

Last Update Submit

November 3, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414

    Pre-dose through 2 days post-dose in each period

  • Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414

    Pre-dose through 2 days post-dose in each period

  • Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414

    Pre-dose through 2 days post-dose in each period

  • Pharmacokinetics (PK): Observed time of maximum concentration (tmax)

    Pre-dose through 2 days post-dose in each period

Study Arms (3)

LY3023414 Reference Fasted

EXPERIMENTAL

Single oral dose of LY3023414 (Reference) on day one fasting.

Drug: LY3023414 Reference Fasted

LY3023414 Test Fasted

EXPERIMENTAL

Single oral dose of LY3023414 (Test) on day one fasting.

Drug: LY3023414 Test Fasted

LY3023414 Test Fed

EXPERIMENTAL

Single oral dose of LY3023414 (Test) on day one after a meal.

Drug: LY3023414 Test Fed

Interventions

LY3023414 Reference FastedDRUG

Administered Orally

LY3023414 Reference Fasted
LY3023414 Test FastedDRUG

Administered Orally

LY3023414 Test Fasted
LY3023414 Test FedDRUG

Administered Orally

LY3023414 Test Fed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy surgically sterile or postmenopausal females and sterile males
  • Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening

You may not qualify if:

  • Cannot be investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
  • Cannot be Lilly employees
  • Have known allergies to LY3023414, related compounds, or any components of the formulation
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 29, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

US(1)