A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aims of this study are to evaluate:

• The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)

• The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Treprostinil

Criteria

Inclusion Criteria:

• Overtly healthy Japanese

• Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)

• Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)

• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

• Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

• Have participated in a clinical trial involving an investigational product within the 30 days before study entry.

• Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product

• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study