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

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Safety and Tolerability of Subcutaneous Treprostinil and Pharmacokinetics of a Novel LY900014 Formulation in Healthy Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treprostinil
* Drug: Placebo
* Drug: LY900014
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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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 Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product Have or used to have health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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treprostinil (Part A)<br>Treprostinil administered as a single subcutaneous (SC) bolus injection. | Drug: Treprostinil<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered as a single SC bolus injection. | Drug: Placebo<br>* Administered SC.<br>|
| Experimental: LY900014 (Part B)<br>LY900014 (test) administered as a single SC bolus injection. | Drug: LY900014<br>* Administered SC.<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Insulin Lispro (Part B)<br>Insulin lispro (reference) administered as a single SC bolus injection. | Drug: Insulin Lispro<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module. | Part A: Baseline through Study Completion (up to 14 Days after Last Dose) | 
| Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B) | PK: Insulin Lispro 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 Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B) | PK: Insulin Lispro 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A) | PK: Treprostinil Tmax (Part A) | 15, 30, 60 and 120 Minutes Postdose | 
| PK: Maximum Concentration (Cmax) of Treprostinil (Part A) | PK: Cmax of Treprostinil (Part A) | 15, 30, 60 and 120 Minutes Postdose |