A Study of LY2157299 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY2157299

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965808

15239

H9H-MC-JBAU (Other Identifier)

Details and patient eligibility

About

Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.

Enrollment: 16 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy sterile males or females
• Are able to eat a high fat meal
• No abnormal heart function or high blood pressure
• No participation in a clinical trial within 30 days
• No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B

Exclusion criteria

• Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

LY2157299 (Fasted)

Experimental group

Description:

Single dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods.

Treatment:

Drug: LY2157299

LY2157299 (Fed)

Experimental group

Description:

Single dose of 150 mg LY2157299 administered orally in fed state in one of two study periods.

Treatment:

Drug: LY2157299