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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Treprostinil; Drug: LY900014; Drug: Insulin Lispro

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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• Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Antihypertensive Agents; Insulin Lispro; Treprostinil
• Other Study ID Numbers: 16071; I8B-JE-ITRK (Other Identifier: Eli Lilly and Company)