A Study of LY3337641 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Reference Formulation (R); Drug: LY3337641 (T1); Drug: LY3337641 (T2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03099148

I8K-MC-JPDF (Other Identifier)

16298

Details and patient eligibility

About

The purposes of this study are to determine:

• If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
• How a high-fat meal affects the amount of LY3337641 in the blood/body.
• How safe and well tolerated LY3337641 is.

The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.

Enrollment: 29 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy males or females, as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
• Have clinical laboratory test results within normal reference range for the population or investigative site
• Are able and willing to give signed informed consent

Exclusion criteria

• 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 significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), 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 used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

LY3337641 (R-fasted)

Experimental group

Description:

A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods.

Treatment:

Drug: Reference Formulation (R)

LY3337641 (T1-fasted)

Experimental group

Description:

A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.

Treatment:

Drug: LY3337641 (T1)

LY3337641 (T1-fed)

Experimental group

Description:

A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods.

Treatment:

Drug: LY3337641 (T1)

LY3337641 (T2-fasted)

Experimental group

Description:

A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods.

Treatment:

Drug: LY3337641 (T2)