A Study of LY2835219 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY2835219

Study type: Interventional

Funder types: Industry

Identifiers

NCT02059148

15175

I3Y-MC-JPBG (Other Identifier)

Details and patient eligibility

About

Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy sterile males or surgically sterile or postmenopausal females
• Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
• Are able to eat a high-fat, high-calorie meal

Exclusion criteria

• Participated in a clinical trial involving investigational product within 30 days
• Abnormal blood pressure
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have donated blood of more than 500 milliliter (mL) within the last month
• Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

LY2835219 Standard

Experimental group

Description:

Single oral dose of LY2835219 given with a standard meal in one of three study periods.

Treatment:

Drug: LY2835219

LY2835219 Fasted

Experimental group

Description:

Single oral dose of LY2835219 given with no food in one of three periods.

Treatment:

Drug: LY2835219

LY2835219 High-Fat

Experimental group

Description:

Single oral dose of LY2835219 given with a high fat meal in one of three periods.

Treatment:

Drug: LY2835219