NCT02385084

Brief Summary

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

October 29, 2018

Completed
Last Updated

October 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

March 5, 2015

Results QC Date

March 24, 2018

Last Update Submit

March 24, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021

    Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period

  • PK: Maximum Plasma Concentration (Cmax) of LY2409021

    Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period

Study Arms (5)

Part A: LY2409021 Capsule

EXPERIMENTAL

Single oral dose of LY2409021 capsule in one of three study periods.

Drug: LY2409021

Part A: LY2409021 Tablet Pre-commercial

EXPERIMENTAL

Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.

Drug: LY2409021

Part A: LY2409021 Tablet Commercial

EXPERIMENTAL

Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.

Drug: LY2409021

Part B: LY2409021 Capsule

EXPERIMENTAL

Single oral dose of LY2409021 capsule in one of two study periods.

Drug: LY2409021

Part B: LY2409021 Tablet Commercial

EXPERIMENTAL

Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.

Drug: LY2409021

Interventions

LY2409021DRUG

Administered orally

Part A: LY2409021 CapsulePart A: LY2409021 Tablet CommercialPart A: LY2409021 Tablet Pre-commercialPart B: LY2409021 CapsulePart B: LY2409021 Tablet Commercial

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
  • Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m\^2)
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

You may not qualify if:

  • Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have known or ongoing psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance CRU, Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

adomeglivant

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
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 29, 2018

Results First Posted

October 29, 2018

Record last verified: 2018-03

Locations

US(1)