A Study of LY3202626 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3202626 (R-Fasting); Drug: LY3202626 (T1-Fasting); Drug: LY3202626 (T1-Fed)

• Registration Number: NCT03023826
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-18
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• Status Verified: 2021-03
• Results First Submitted: 2021-03-22
• Results First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Results First Posted: 2021-04-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Read More

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• Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3202626 (R-Fasting)	LY3202626 (R-Fasting)	Single oral dose of LY3202626 (R) capsule under fasting conditions.
LY3202626 (T1-Fasting)	LY3202626 (T1-Fasting)	Single oral dose of LY3202626 (T1) tablet under fasting conditions.
LY3202626 (T1-Fed)	LY3202626 (T1-Fed)	Single oral dose of LY3202626 (T1) following a high fat breakfast.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose	Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose	PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626
PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose	PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626

Trial Locations

Locations (1)

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