A Study of LY2835219 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Rifampin; Drug: LY2835219

Study type: Interventional

Funder types: Industry

Identifiers

NCT02256267

15174

I3Y-MC-JPBF (Other Identifier)

Details and patient eligibility

About

The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.

The study will last about 34 days. Screening is required within 28 days before study drug is given.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy sterile males or surgically sterile females or postmenopausal females
• Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

Exclusion criteria

• Have participated in a clinical trial involving investigational product within the last 30 days
• 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 an abnormal blood pressure
• Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
• Have donated blood of more than 500 milliliters (mL) within the last month
• Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

LY2835219

Experimental group

Description:

Single oral dose of LY2835219

Treatment:

Drug: LY2835219

LY2835219 + Rifampin

Experimental group

Description:

Single oral dose of LY2835219 with rifampin orally, once daily for 14 days

Treatment:

Drug: Rifampin

Drug: LY2835219