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

Eli Lilly and Company23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

TreprostinilDRUG

Administered SC.

PlaceboDRUG

Administered SC.

LY900014DRUG

Administered SC.

Insulin Lispro

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product * Have or used to have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

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

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 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)

Time frame: 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 Outcomes

PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)

PK: Treprostinil Tmax (Part A)

Time frame: 15, 30, 60 and 120 Minutes Postdose

PK: Maximum Concentration (Cmax) of Treprostinil (Part A)

PK: Cmax of Treprostinil (Part A)

Time frame: 15, 30, 60 and 120 Minutes Postdose

Data from ClinicalTrials.gov

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