A Study of LY3202626 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3202626 (T1-Fasting); Drug: LY3202626 (T1-Fed); Drug: LY3202626 (R-Fasting)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03023826

I7X-MC-LLCE (Other Identifier)

15567

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

LY3202626 (R-Fasting)

Experimental group

Description:

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

Treatment:

Drug: LY3202626 (R-Fasting)

LY3202626 (T1-Fasting)

Experimental group

Description:

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

Treatment:

Drug: LY3202626 (T1-Fasting)

LY3202626 (T1-Fed)

Experimental group

Description:

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

Treatment:

Drug: LY3202626 (T1-Fed)