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

Phase 1

Completed

Interventions: Drug: LY900014
Drug: Placebo
Drug: Insulin Lispro
Drug: Treprostinil

Brief 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.

Recruitment & Eligibility

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Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product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

Arm && Interventions

Group	Intervention	Description
LY900014 (Part B)	LY900014	LY900014 (test) administered as a single SC bolus injection.
Placebo (Part A)	Placebo	Placebo administered as a single SC bolus injection.
Insulin Lispro (Part B)	Insulin Lispro	Insulin lispro (reference) administered as a single SC bolus injection.
Treprostinil (Part A)	Treprostinil	Treprostinil administered as a single subcutaneous (SC) bolus injection.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Part A: Baseline through Study Completion (up to 14 Days after Last Dose)	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B)	Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose	PK: Insulin Lispro Cmax (Part B)
PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B)	Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose	PK: Insulin Lispro AUC(0-30min) (Part B)

Secondary Outcome Measures

Name	Time	Method
PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)	15, 30, 60 and 120 Minutes Postdose	PK: Treprostinil Tmax (Part A)
PK: Maximum Concentration (Cmax) of Treprostinil (Part A)	15, 30, 60 and 120 Minutes Postdose	PK: Cmax of Treprostinil (Part A)

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇯🇵
Fukuoka, Japan