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Completed

NCT Number: NCT02770521

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

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.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product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

Treatment and study plan

Treprostinil

Drug

Administered SC.

Placebo

Drug

Administered SC.

LY900014

Drug

Administered SC.

Other names: Ultra-Rapid Lispro

Insulin Lispro

Drug

Administered SC.

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: 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.

  2. Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (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 Cmax (Part B)

  3. PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (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

    PK: Insulin Lispro AUC(0-30min) (Part B)

Secondary outcomes

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

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

    PK: Treprostinil Tmax (Part A)

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

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

    PK: Cmax of Treprostinil (Part A)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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