A Study of LY3337641 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2017-05-31

Brief Summary

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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.

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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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LY3337641 (R-fasted)

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

Group Type EXPERIMENTAL

Reference Formulation (R)

Intervention Type DRUG

Administered PO

LY3337641 (T1-fasted)

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

Group Type EXPERIMENTAL

LY3337641 (T1)

Intervention Type DRUG

20 mg PO

LY3337641 (T1-fed)

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.

Group Type EXPERIMENTAL

LY3337641 (T1)

Intervention Type DRUG

20 mg PO

LY3337641 (T2-fasted)

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.

Group Type EXPERIMENTAL

LY3337641 (T2)

Intervention Type DRUG

20 mg PO

Interventions

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Reference Formulation (R)

Administered PO

Intervention Type DRUG

LY3337641 (T1)

20 mg PO

Intervention Type DRUG

LY3337641 (T2)

20 mg PO

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
* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes