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

NCT02770521 | Completed Phase 1 Results

• 2 other identifiers: 16071I8B-JE-ITRK
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

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

  15, 30, 60 and 120 Minutes Postdose

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

  15, 30, 60 and 120 Minutes Postdose

Study Arms (4)

Treprostinil (Part A)

EXPERIMENTAL

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

Drug: Treprostinil

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered as a single SC bolus injection.

Drug: Placebo

LY900014 (Part B)

EXPERIMENTAL

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

Drug: LY900014

Insulin Lispro (Part B)

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

Interventions

Treprostinil DRUG

Administered SC.

Treprostinil (Part A)

Placebo DRUG

Administered SC.

Placebo (Part A)

LY900014 DRUG

Administered SC.

Also known as: Ultra-Rapid Lispro

LY900014 (Part B)

Insulin Lispro DRUG

Administered SC.

Insulin Lispro (Part B)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 812-0025, Japan

Location

MeSH Terms

Interventions

treprostinil; Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2016-07

Locations

JP (1)