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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770521
• Other study ID #: 16071
• Secondary ID: I8B-JE-ITRK
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

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• Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Treprostinil
Administered SC.
• Placebo
Administered SC.
• LY900014
Administered SC.
• Insulin Lispro
Administered SC.

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)	PK: Treprostinil Tmax (Part A)	15, 30, 60 and 120 Minutes Postdose
Secondary	PK: Maximum Concentration (Cmax) of Treprostinil (Part A)	PK: Cmax of Treprostinil (Part A)	15, 30, 60 and 120 Minutes Postdose