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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treprostinil (Part A)

Treprostinil administered as a single subcutaneous (SC) bolus injection.

Group Type EXPERIMENTAL

Treprostinil

Intervention Type DRUG

Administered SC.

Placebo (Part A)

Placebo administered as a single SC bolus injection.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

LY900014 (Part B)

LY900014 (test) administered as a single SC bolus injection.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC.

Insulin Lispro (Part B)

Insulin lispro (reference) administered as a single SC bolus injection.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC.

Interventions

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Treprostinil

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

LY900014

Administered SC.

Intervention Type DRUG

Insulin Lispro

Administered SC.

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes