A Study of LY900014 Formulations in Healthy Participants

NCT02317575 | Completed Phase 1 Results

• 2 other identifiers: 15645I8B-FW-ITRA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)

  30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Secondary Outcomes (4)

• Part A: Visual Analog Scale (VAS) Score for Injection Site Pain

  Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure

• Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp

  Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdose

• Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability

  Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdose

• Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability

  Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Study Arms (6)

Part A: LY900014 Test A

EXPERIMENTAL

Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.

Biological: LY900014

Part A:Insulin Lispro

EXPERIMENTAL

Reference formulation. 15 U insulin lispro administered SC in one of five periods.

Biological: Insulin Lispro

Part A: LY900014 Test B

EXPERIMENTAL

Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.

Biological: LY900014

Part A: LY900014 Test C

EXPERIMENTAL

Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.

Biological: LY900014

Part A: LY900014 Test D

EXPERIMENTAL

Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.

Biological: LY900014

Part B: LY900014

EXPERIMENTAL

Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.

Biological: LY900014

Interventions

LY900014 BIOLOGICAL

Administered SC

Also known as: Ultra-Rapid Lispro

Part A: LY900014 Test A; Part A: LY900014 Test B; Part A: LY900014 Test C; Part A: LY900014 Test D; Part B: LY900014

Insulin Lispro BIOLOGICAL

Administered SC

Also known as: LY275585

Part A:Insulin Lispro

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
• Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
• Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

You may not qualify if:

• Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• 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.

Singapore, 117597, Singapore

Location

MeSH Terms

Interventions

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

Limitations and Caveats

Part B was not executed per protocol because no formulation was identified in Part A.

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: Yes
• 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: December 11, 2014
• First Posted: December 16, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 13, 2020
• Results First Posted: May 13, 2020

Record last verified: 2015-09

Locations

SG (1)