A Study of LY2835219 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ¹³C₈-LY2835219; Drug: LY2835219

Study type: Interventional

Funder types: Industry

Identifiers

NCT02327143

15533

I3Y-MC-JPBS (Other Identifier)

Details and patient eligibility

About

The aim of this 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 as an intravenous infusion (given directly into a vein via a small needle).

The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.

The study will last about 10 days. Screening is required within 28 days before study drug is given.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 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)
• Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
• Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

• Have participated in a clinical trial involving investigational product within the last 90 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 consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 2 patient groups

200 mg LY2835219

Experimental group

Description:

200 mg LY2835219 administered orally on day 1.

Treatment:

Drug: LY2835219

0.4 mg ¹³C₈-LY2835219

Experimental group

Description:

0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.

Treatment:

Drug: ¹³C₈-LY2835219