A Study of LY3202626 in Healthy Participants

NCT ID: NCT03023826

Last Updated: 2021-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2017-04-04

Brief Summary

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The purposes of this study are to determine:

* If there are any differences in the way LY3202626 is handled by the body when taken in two different forms
* Whether a high fat meal affects the way the body handles LY3202626
* How well tolerated LY3202626 is

There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

The study will last about 50 days, not including screening.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3202626 (R-Fasting)

Single oral dose of LY3202626 (R) capsule under fasting conditions.

Group Type EXPERIMENTAL

LY3202626 (R-Fasting)

Intervention Type DRUG

Administered orally

LY3202626 (T1-Fasting)

Single oral dose of LY3202626 (T1) tablet under fasting conditions.

Group Type EXPERIMENTAL

LY3202626 (T1-Fasting)

Intervention Type DRUG

Administered orally

LY3202626 (T1-Fed)

Single oral dose of LY3202626 (T1) following a high fat breakfast.

Group Type EXPERIMENTAL

LY3202626 (T1-Fed)

Intervention Type DRUG

Administered orally

Interventions

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LY3202626 (R-Fasting)

Administered orally

Intervention Type DRUG

LY3202626 (T1-Fasting)

Administered orally

Intervention Type DRUG

LY3202626 (T1-Fed)

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy males or females, as determined by medical history and physical examination
* Female participants must be of non-childbearing potential confirmed by medical history or menopause
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria

* Are investigative site personnel directly affiliated with this study and their immediate families
* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Have a history of head trauma with loss of consciousness within the last 5 years
* Have known or ongoing psychiatric disorders
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Singapore, , Singapore

Site Status

Countries

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Singapore

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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I7X-MC-LLCE

Identifier Type: OTHER

Identifier Source: secondary_id

15567

Identifier Type: -

Identifier Source: org_study_id

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